Spinal Times: The Amy Alexander Foundation for Spinal Cord Injuries

THURSDAY, Dec. 24 (HealthDay News) -- Vitamin C is often recommended to help fight the common cold and heal wounds, but the antioxidant might have another benefit: it appears to help adult cells generate embryonic-like stem cells, new research suggests.

The findings, published online Dec. 24 in the journal Cell Stem Cell, add to previous research that showed how adult cells can be reprogrammed. The problem, researchers explained, is that the process doesn't work very well.

"The low efficiency of the reprogramming process has hampered progress with this technology and is indicative of how little we understand it. Further, this process is most challenging in human cells," senior study author Duanqing Pei, of the South China Institute for Stem Cell Biology and Regenerative Medicine at the Guangzhou Institutes of Biomedicine and Health, Chinese Academy of Sciences, said in a news release from the journal's publisher.

The researchers found that vitamin C boosted the process in both human and mouse cells.

"It is also of interest that a vitamin with long-suspected anti-aging effects has such a potent influence on reprogramming, which can be considered a reversal of the aging process at the cellular level. It is likely that our work may stimulate further research in this area as well," Pei added.

New ethical questions are being raised in stem cell research

A groundbreaking discovery two years ago that turned ordinary skin cells back into an embryonic or "pluripotent" state was hailed as the solution to the controversial ethical question that has plagued stem-cell science for the past decade.

But is it the solution? Or have iPS cells (induced pluripotent stem cells) simply added a new dimension to the legal, social and ethical debates that are an important and necessary part of stem-cell advances.

This was the central question discussed by an international group of leading scientists, bioethicists and legal scholars who attended a workshop organized by the Stem Cell Network this summer in Barcelona. Outcomes of the workshop will be published Dec. 10 in the journal Cell. Among the issues summarized in the article are consent, privacy, clinical translation and intellectual property rights for iPS cells that are derived for scientific study and/or clinical therapies.

Timothy Caulfield, research director at the University of Alberta's Health Law Institute and principal investigator at the Stem Cell Network, says that while iPS technology eliminates some of the ethical issues specific to embryonic stem-cell research it also adds new challenges.

"From a legal perspective, iPS technology is fascinating and complex. For example, if an iPS cell can be made into a functional human gamete, the potential exists for reproductive purposes. What would this mean for donor consent, concerns about cloning and rights of a potential child to know its parents," said Caulfield.

"What could this mean to assisted reproduction practices and would-be parents with no other option? If anything, we know considerable thought and policy development needs to be placed around these and other issues."

Michael Rudnicki, scientific director of the Stem Cell Network, agrees and says the promise of stem cell advances using iPS cells is staggering. "If iPS cells can be made safe for clinical therapies, it will ultimately make the delivery faster and more economical. But as a scientist I am cautious. So much is based on future prospects and there is much work that needs to be done in the labs before it becomes a therapeutic reality," says Rudnicki.

Embryos power U-M stem cell research

University begins accepting donations, gets FDA OK for first Lou Gehrig's disease study

KIM KOZLOWSKI
The Detroit News

The University of Michigan will now be accepting donated human embryos to create embryonic stem cell lines, launching research aimed at improved treatments for diseases, researchers said Tuesday.

The announcement means that U-M can begin long-awaited research on incurable illnesses like Lou Gehrig's disease. State restrictions on such research were lifted last year when voters approved a constitutional amendment.

It already has put Michigan in the stem cell spotlight, academically and economically, as U-M joins a small class of other universities nationwide that are creating stem cell lines to do ground-breaking science. But it comes as some lawmakers are trying to pass bills to add parameters that some say would stymie the progress the state has made.

"This is the beginning of a new era," said Eva Feldman, a U-M researcher and neurologist.

For years, proponents of stem cell research tried to change Michigan's law, among the most restrictive in the nation. But the effort dragged on since it was rebuffed by those who view embryonic stem cell research as immoral for the destruction of embryos created through in-vitro fertilization that are no longer needed.

After voters approved the constitutional amendment in November 2008, residents began asking U-M how they could donate their frozen embryos left over from in-vitro fertilization. But the university needed to develop a consent process and get it approved by university committees before the work could begin.

"We wanted to do it right," said Gary Smith, co-director of the U-M Consortium for Stem Therapies, which joins a handful of universities nationwide creating stem cell lines.

'Unprecedented potential'

Since the vote, $6.8 million in federal stimulus dollars have been awarded to Michigan stem cell researchers. Detroit was selected as the site for the 2010 World Stem Cell Summit, a global gathering of researchers, entrepreneurs and policymakers. The Food and Drug Administration also approved the first clinical trial of stem cells involving humans with Lou Gehrig's disease to be overseen by Feldman.

"I am convinced (stem cell research) is one of the best opportunities to attract investment, create jobs and emerge from this recession with a revitalized economy," said A. Alfred Taubman, who invested millions into passing the constitutional amendment and the U-M Consortium for Stem Cell Therapies after watching a friend die from Lou Gehrig's disease. "It also has unprecedented potential to cure diseases that affect millions of people around the world. But there are people who want to undo the progress we've made."

Today, a Senate subcommittee is poised to vote on a package of bills that proponents say would add definition to the constitutional amendment. Opponents say it would gut the will of the people.

That's not true, said Sen. Tom George, R-Kalamazoo, and head of the Senate Health Policy Committee. George says the package makes the amendment clearer and includes penalties and fines for violating the law. He added the laws are necessary for the private sector conducting stem cell research since it is not bound by federal guidelines.

"Vagaries in the law are no good for anyone," said George.

Feldman, the keynote speaker Tuesday at a Detroit Economic Club luncheon at the Westin Book Cadillac in Detroit, said the bills would limit researchers to only being able to create and freeze stem cell lines. If the bills were passed, researchers could not work on incurable diseases or other research that could lead to better therapies for people suffering from diseases such as juvenile diabetes, dementia and Parkinson's.

It took months for U-M to be ready to create its first embryonic stem cell lines, which are constantly dividing cells originating from a stem cell, because the work needed to be approved by two university committees.

Life sciences sector growing

The state is taking steps to diversify the economy, Feldman said. She also noted that the life sciences sector in Michigan over a seven-year period grew 10.7 percent while manufacturing declined 24.7 percent. "There's excitement, there's investment in stem cell research," said Feldman.

Kathleen Russell, who has suffered from Parkinson's nearly 12 years, said 40,000 people also suffer from the debilitating movement disorder.

But her faith taught her that a mustard seed can move a mountain, she said.

"For us, embryonic stem cells are indeed smaller than a mustard seed," said Russell, an Ann Arbor resident who attended the luncheon to support continued stem cell research in Michigan.

"But it has the scientific power to move mountains."

Additional Facts To donate

For information on donating human embryos to U-M, visit http://stemcellresearch.umich.edu.

New stem cell lines approved for tax-paid research

By LAURAN NEERGAARD

AP Medical Writer

Scientists can start using taxpayer dollars to do research with 13 batches of embryonic stem cells and the government says dozens more cell lines should be available soon, opening a new era for the potentially life-saving field.

President Barack Obama lifted eight years of restrictions on these master cells last spring. But $21 million-and-counting in new projects were on hold until the National Institutes of Health determined which of hundreds of existing stem cell lines were ethically appropriate to use.

"This is the first down payment," Dr. Francis Collins, NIH's director, said Wednesday as he opened a master registry. "People are champing at the bit for the opportunity to get started."

Thirteen stem cell lines - created by Children's Hospital Boston and Rockefeller University - are first on that list. Another 96 embryonic stem cell lines are undergoing NIH review, and 20 or more could get a decision by Friday, Collins said.

And researchers have notified the NIH that they may apply for approval of another 250 stem cell lines.

"The field has been waiting with bated breath for this announcement," said Dr. George Daley of Children's Hospital Boston, whose lab created 11 of the newly approved lines. He has about 100 vials of cells from each batch already banked and ready to ship to researchers around the country.

The numbers mark a big change from the Bush administration, which had limited taxpayer-funded research to about 21 stem cell lines, those already in existence as of August 2001. Scientists say newer batches were created in ways that made them far better candidates for successful research. Indeed, only one of the Bush-era stem cell lines is among the 96 now under consideration.

Wednesday's announcement means that researchers who were awarded $21 million in stem cell research grants earlier this year can start using the approved lines immediately, projects that include work to one day repair damaged heart tissue and grow new brain cells. Millions more in stem cell money is due out later this winter, funds from the economic stimulus package.

Embryonic stem cells can morph into any cell of the body, and scientists hope to harness them so they can create replacement tissue to treat, possibly even cure, a variety of diseases, from diabetes to Parkinson's to spinal cord injury.

Culling those cells destroys a days-old embryo, something many strongly oppose on moral grounds. But once created, the cells can propagate indefinitely in lab dishes.

Federal law forbids using taxpayer money to create or destroy an embryo. All the stem cell lines involved in Wednesday's announcement were created from fertility clinic leftovers - embryos that otherwise would have been thrown away - using private money. NIH is reviewing the rest to see if they also meet ethics requirements for use in taxpayer-funded health research. Among the requirements: That the woman or couple who donated the original embryo did so voluntarily and were told of other options, such as donating to another infertile woman.

Why do scientists need so many choices? It's not just to supply the demand of a growing field. There's a lot of variability from batch to batch in how the stem cells perform, Daley said. Some are better at turning into blood-producing cells than muscle-producing ones, for instance.

It has to do with the genetics of the original embryo, and probably also with the recipe used to create and nurture the stem cells - an environment that can trigger genes to switch on and off at different times, explained Daley, who has government funding to study those important differences.

First New Embryonic Stem Cell Lines Approved for U.S.

By Rob Waters

Dec. 2 (Bloomberg) -- Thirteen embryonic stem-cell lines were approved for use by U.S.-funded researchers today, the first of hundreds of cell colonies that may become available under new polices promised by President Barack Obama.

Stem cells taken from days-old human embryos can be kept alive indefinitely in solution, and have the ability to turn into about 200 cell types in the body. Use of these so-called cell lines is opposed by some people because extracting them destroys the embryos. The stem-cell expansion was announced today by Francis Collins, director of the National Institutes of Health, in a telephone briefing with reporters.

Another 20 lines may be cleared as soon as Dec. 4, the first of “a wave” of approvals that could make hundreds available, Collins said. Obama pledged to end U.S. stem-cell restrictions during his presidential campaign. Congress twice voted to overturn the limits, put in place by President George W. Bush, and Bush vetoed both measures.

“With these restrictions now being lifted, we can now compete, hopefully, with the U.K. and some of the other foreign governments that are running with us,” said Robert Lanza, chief scientific officer of Worcester, Massachusetts-based Advanced Cell Technology Inc., in a telephone interview today. “It would be good for us to be back in the game.”

Advanced Cell gained 1 cent to reach 11 cents in over-the- counter trading at 4 p.m. New York time. The shares more than tripled this year. Geron, the Menlo Park, California company whose application to start the first human trial using embryonic stem cells is pending before the U.S. Food and Drug Administration, rose 76 cents, or 14 percent, to $6.20 in Nasdaq Stock Market trading. The increase was the biggest single-day gain for the company in more than four months.

10,000 Shares

Redwood Partners, a New York-based investment firm, bought 10,000 shares of Geron at $5.70 off the news, said Lisa Duffee, a trader with the company, in a telephone interview today.

“These sorts of stocks get crazy when there’s news,” she said. “They react strongly to the upside or the downside and they’re not expensive. We may hold on to them for a few days to see how much noise it gets. If it really runs up, we could be out today.”

The newly approved lines were created by George Daley, a researcher at Harvard University in Cambridge, Massachusetts and Ali Brivanlou, a researcher at Rockefeller University in New York. They were made using private donations during the eight years that federal funding for stem-cell research was sharply restricted by the Bush administration.

‘Huge Relief’

“It’s been a long time coming and it’s a huge relief,” said Daley, whose research team at the Harvard Stem Cell Institute created 11 of the newly approved lines. “This is the first step toward widely expanded access to hundreds of lines that have been derived since the initial Bush policy of 2001.”

Collins said his agency has approved 31 grants totaling $21 million that have been held up until new cell lines were reviewed and approved. The scientists awarded the grants can now choose which approved cell lines to work with, he said.

“This is an opportunity to celebrate the science that can now go forward,” Collins said during the briefing. The announcement should end “what has clearly been a time of some frustration on the part of the research community.”

More embryonic stem-cell grant applications are under review by the NIH as part of the $10 billion provided to the agency in the $787 stimulus package passed by Congress in February, Collins said. Those grants are in the second stage of scrutiny at the agency and may lead to more than $10 million in additional awards, he said.

‘Rigorous’ Review

The NIH conducted a “rigorous” review to make sure the stem cells approved today were made from embryos that were freely donated by women who were not compensated or induced in any way to provide them, Collins said. Scientists had to submit evidence that donors were informed of all options on use of their embryos and provided written consent.

David Prentice, a senior fellow for life sciences at the Family Research Council in Washington, described the new approvals as “unfortunate,” saying stem-cell research had yet to produce results.

“This money would be much better spent on adult stem cell research where we are seeing good results for a variety of diseases including stroke, spinal cord injury and multiple sclerosis,” he said.

Eye Diseases

Advanced Cell Technology applied to U.S. regulators last month to start human trials on its embryonic stem-cell treatment for Stargardt’s Macular Dystrophy, which causes untreatable blindness. The treatment resulted in 100 percent restoration of vision in rat studies with no serious side effects, Lanza said.

The stem-cell colony used in the studies, which wasn’t previously approved for federal research funding, is five to ten times as efficient at replacing lost photoreceptor cells as other lines, Lanza said.

The company plans to pursue the treatment for other forms of macular degeneration, which affects as many as 10 million people in the U.S., according to a company statement.

To contact the reporter on this story: Rob Waters in San Francisco at rwaters5@bloomberg.net.

Medicine's Next Big Thing: No More Pain Pills?

BOSTON (Ivanhoe Newswire) -- The annual cost of chronic pain in the U.S. is estimated to be $100 billion. Nearly 5 million people go to their doctors for relief from the condition, but meds can wear off, and patients run the risk of addiction. Researchers are working on a new approach to chronic pain in the form of an injection that could ease the discomfort for days

For Meri Kennedy, cleaning isn't just tedious -- it's painful. Every ache is a reminder of a life-long battle with chronic pain, the result of a long list of health complications.

"Fractured ribs, polyps in my vocal chord, breast cancer, fractured hip, injury to my knee," Kennedy said.

Kennedy relies on pain meds to get through the day.

"I am afraid I can get addicted to the pain meds," she said.

Soon, people like Kennedy may be able to stop the pill popping and get one injection that blocks pain for days.

"We have developed some liposomes which, when injected either into the tissue or a nerve area, can numb the area for about a week," Dan Kohane, M.D., Ph.D., Senior Associate of Critical Care at Children's Hospital Boston, told Ivanhoe.

Liposomes are specially designed fat-based particles that hold pain meds.

"When injected, liposomes just sit there and let the drugs leave," Dr. Kohane explained.

The liposomes slowly release a potent anesthetic over time. In animal studies, the technique blocked nerves without damaging surrounding cells or muscles.

"The main advantages of this type of formulation over taking a narcotic, for example, to the best of our knowledge these have no addictive potential but can treat the pain," Dr. Kohane said.

"I would welcome it, definitely," Kennedy said.

One shot … days of relief. For chronic pain sufferers, it could turn the chores of daily life into much more pleasant experiences.

The anesthetic used in the study is a toxin naturally found in certain bacteria and pufferfish.

For Sale: Human Eggs Become a Research Commodity.

a decision to pay for eggs for stem cell studies sparks debate

By Katherine Harmon

Paying a woman for her eggs to use in stem cell research has been a bioethical no-no for years. But this past June, New York State decided to allow just that, becoming the first state to permit public money to be used in this way. The decision, which allows payment of up to $10,000, will likely jump-start donations—and thereby research. Many bioethicists, however, worry that the financial incentive could exploit women and compromise their health.

Ethical issues surround egg donation because the process is not without risk. It requires a series of hormonal stimulation injections as well as an invasive procedure to retrieve the eggs. The long-term health effects and risks of complication are not well known. A woman who provides eggs for research is “assuming unknown risk for unknown benefits,” says Debra Mathews, a geneticist at Johns Hopkins University. The lingering unknowns prompted the National Academy of Science to issue in 2005 nonbinding guidelines to prohibit payment (but allow direct reimbursement for expenses), as a means to protect underprivileged women in particular.

Various research teams have observed those guidelines and tried to recruit women to donate their eggs for free. But these altruism-dependent attempts failed to find any takers. Instead scientists have primarily relied on eggs left over from in vitro fertilization (IVF) procedures. The secondhand supply, however, is small, and some question the quality of these eggs. Many may have been rejected for implantation because they were subpar to begin with. Storage and transport can also be problematic; as Mathews explains, “We’re not good at freezing and thawing eggs yet.”

The lack of quality eggs, along with an 11-year, $600-million directive from the New York State legislature to further stem cell research, persuaded New York’s Empire State Stem Cell Board to allow payment to women for egg donation. The board governs publicly funded stem cell work and is in charge of overseeing grants for related research.

Proponents of the board’s decision note that payment for similar services is not unheard of. “We pay people to participate in research that has zero benefit to them [but carries] risk all the time, and we trust people to make that decision for themselves,” says Mathews, who is also a member of the Johns Hopkins Berman Institute of Bioethics. Other bioethicists, including Insoo Hyun of the Case Western Reserve University School of Medicine, echo that sentiment. Hyun wrote a 2006 commentary piece in Nature in which he argued that just like others who volunteer for research, women should be paid to donate eggs for stem cell studies. (Scientific American is part of the Nature Publishing Group.) Moreover, research donations do not have to be seen as something different from fertility donations, points out Ronald Green, director of the Ethics Institute at Dartmouth College. “In a sense, infertility is a disease, so women are helping [other] women overcome a disease,” just as they could be helping to find treatments for additional diseases.

Opponents worry that offering up large sums of money for egg donation may be too good an offer for some women to pass up—especially those who might not qualify for paid fertility donation, which screen women based on intellectual and physical attributes. The financial incentives might also drive some to overdonate, Green notes. He says that some “serial egg donors” have donated some 20-odd times, risking their own health and reproductive abilities. He recommends some kind of national register to keep track of donations and ensure that women give no more than a few times.

The move to pay for eggs destined for research may also reflect changing mores. In 1978 the birth of Louise Brown, the world’s first baby to be conceived by IVF, set off much debate about the control of embryos, women’s reproductive rights and ominous Brave New World correlations. Yet test-tube babies became common, and since 1978 more than three million have been born worldwide. Except when it is used to select and screen embryos for certain characteristics, the procedure brings along little ethical hand-wringing today—even with its hefty financial rewards to female donors.

The debate might eventually be a moot point, as researchers continue to make convincing headway with induced pluripotent cells, which seem to have all the properties of embryonic stem cells but which are created from adult cells. But both Mathews and Green acknowledge that creating a functional egg from skin or other cells still looks to be a long way off. “Generally the science moves pretty slowly and incrementally,” Mathews says. “It’s always difficult to predict, but if we could predict it, it wouldn’t be science.”

Note: This article was originally printed with the title, "Shelling Out for Eggs."

From the Daily: Progress makes perfect.

By The Michigan Daily On November 5th, 2009

A year after the historic election of President Barack Obama, the verdict may still be out as to whether he’s living up to expectations. But for voters in Michigan, this year’s Election Day marked another important one-year anniversary — the state’s approval of ballot initiatives legalizing medical marijuana and expanding stem cell research. While these progressive measures were intended to provide relief for the chronically ill, they are affecting many residents of Michigan in positive ways. A year after their approval, positive developments are occurring on both the stem cell and medical marijuana fronts — and Michigan must continue to be a leader on these issues.

In last year’s election, Michigan became the 13th state to allow certain patients with specific medical conditions to use marijuana. With permission from a doctor, patients gained the legal right to cultivate and use marijuana to help relieve their symptoms. But the legalization process has not been seamless — with some users still facing unjust legal repercussions — nor has it provided a method for users to obtain marijuana short of growing it themselves or using approved sources. Supporters of medical marijuana rallied in Lansing in early October for clear regulations to make use easier.

In addition to removing legal hurdles to medical marijuana use, the state government needs to make sure it doesn't fall behind other governing bodies that are beginning to adopt even more lenient marijuana policies. Marijuana usage should be legal, for medical and non-medical reasons, and public sentiment is slowly but surely turning in favor of such a position. Indeed, supporters in California are preparing to launch a ballot initiative campaign calling for total legalization. Even the U.S. Justice Department is is shifting opinion, announcing last month that federal officials wouldn’t arrest patients following state laws regarding medicinal marijuana use.

Michigan is ahead of much of the country in legalizing a safe, already widely practiced behavior. But the state can do even better. Michigan should continue to push the envelope, allowing users to obtain marijuana more easily and eventually aiming for total legalization.

And while Michigan can be said to be at the head of the pack on marijuana reform, the state is even stronger on stem cell reform. Last year’s Proposal 2 lifted restrictions on stem cell research, instantly making Michigan competitive with other states in a promising field of study that has the potential to cure diseases and save lives. And as a sign of the state’s progress, Gov. Jennifer Granholm announced on Oct. 15 that Detroit would be the site of the 2010 World Stem Cell Summit. The event will be co-hosted by the University, Michigan State University, Wayne State University and the Michigan Economic Development Corporation.

Michigan must keep its place at the forefront of stem cell research. Aside from the obvious benefit of saving lives, increased stem cell research brings the best minds to our universities and the state. This will create jobs and expand the state’s industries into cutting-edge research and development fields, facilitating an economic transformation.

One year after the passage of these beneficial and progressive amendments, Michigan stands at the forefront of important social and economic changes. State policy must continue to push the envelope on these issues in the years to come.

Printed from www.michigandaily.com on Fri, 20 Nov 2009 14:37:50 -0500

Detroit hosting stem cell summit in 2010

DETROIT (AP)- Michigan Gov. Jennifer Granholm and Detroit Mayor Dave Bing have confirmed the city will be the host of a convention next October on stem cell research and commercialization.

Officials announced Thursday the World Stem Cell Summit will bring its annual event to downtown's Detroit Marriott at the Renaissance Center Oct. 4-6. Also involved are the University of Michigan, Michigan State University and Wayne State University.

The summit is expected to include progress reports on proposed stem cell treatments for cancer, diabetes, spinal cord injury and other diseases.

The event, organized by the Genetics Policy Institute, is expected to draw more than 1,200 business, academic and government leaders from 25 countries. This year's summit was held last month in Baltimore.

From the Associated Press

Stemedica Completes Meeting With The FDA

Stemedica Cell Technologies, Inc. (Stemedica), a world leader in stem cell research and manufacturing, announced that it completed its pre-IND meeting with the U.S. Food and Drug Administration (FDA) regarding a proposed IND (Investigative New Drug) to evaluate the safety and efficacy of Stemedica's high potency proprietary allogeneic mesenchymal bone marrow-derived stem cells (adult human) as a treatment for ischemic stroke. Based on a meeting October 13, 2009 with the FDA, Stemedica is planning to file an IND application in the first quarter of 2010.

The proposed clinical trial will be a Phase I/II dose escalation and safety clinical trial using allogeneic mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke. The patient population will include individuals with a clinical diagnosis of chronic neurological or age-related neurodegenerative disease with significant functional or neurologic impairment that confines the subject to a wheelchair or requires the subject to have home nursing care or assistance with the general activities of daily living. The proposed trial will take place at medical centers within the United States.

"This is an important milestone for Stemedica," said Nikolai Tankovich, MD, PhD, Stemedica's President and Chief Medical Officer. "In addition to the official licensing of our manufacturing facility in San Diego, California, we can now establish our own clinical trial pathways for our various products. Stemedica's goal is to receive regulatory approvals for the clinical application of all of its products."

"With constructive feedback from the FDA we can work on fine-tuning the proposed treatment protocol and advance our proposed clinical trial to targeted medical facilities for full consideration," said Michael Levy, MD, PhD. Dr. Levy is the Chief of Pediatric Neurosurgery, Rady Children's Hospital of San Diego, Professor of Surgery, UCSD School of Medicine and the Principal Investigator for the proposed clinical trial.

Stemedica was granted its license by the State of California's Department of Public Health, Food and Drug Branch to manufacture stem cells for clinical trials in July, 2009. The Drug Manufacturing License grants Stemedica the right to manufacture clinical-grade (for human use) drug or biologic products and recognizes Stemedica as being compliant with California law and the applicable provisions of the Code of Federal Regulations.

About Stemedica Cell Technologies, Inc.

Stemedica Cell Technologies Inc. is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company is currently developing regulatory pathways for stroke and wound repair. Stemedica is headquartered in San Diego, California.

Source: Stemedica Cell Technologies, Inc

Regents agenda doesn't include stem-cell research

The agenda for the University of Nebraska Board of Regents meeting next Friday is out, and stem-cell research isn't listed as a topic of discussion -- at least not yet.

Agenda items can be added up to 24 hours before the meeting.

Nebraska Right to Life has called on its allies to picket outside the meeting, urging regents not to allow expanded embryonic stem-cell research at the University of Nebraska Medical Center.

Expansion became possible under President Barack Obama, who relaxed rules on the research that had been put in place by former President George W. Bush.

Supporters of embryonic stem-cell research believe it could lead to treatments for diseases like Parkinson's and diabetes.

But because harvesting embryonic stem cells requires destroying an embryo, some find the practice morally objectionable.

State law prohibits the creation and destruction of embryos at will, and any embryonic stem cells UNMC researchers would gain access to would come from embryos left over from fertility treatments.

Opponents of embryonic stem-cell research want regents to make sure UNMC scientists conduct the research only on stem-cell lines approved under Bush. That would require a change in regents policy, since current policy simply says UNMC researchers must abide by federal guidelines in their work.

Supporters of the research, meanwhile, want the policy to remain so UNMC scientists could gain access to new stem-cell lines approved under Obama.

Though regents are feeling pressure from both sides, several board members told the Journal Star this week they wouldn't let themselves be rushed into an early decision.

Reach Melissa Lee at 473-2682 or mlee@journalstar.com.

Nobelists Rising

An article at Science Progress looks at new Noblist Elizabeth Blackburn's tenure on George W. Bush's President's Council on Bioethics. The article says that Blackburn's progressive stance on human embryonic stem cell research irked the administration. Blackburn was appointed to the council in 2001 and her tenure was not renewed three years later. Blackburn then wrote: "In a telephone call from the White House one Friday afternoon in February, I was told that my services were no longer needed. The only explanation I was offered was that 'the White House has decided to make some changes in the bioethics council.'"

Another new Nobel-winner, Venkatraman Ramakrishnan, speaks out against Britain's research funding reforms, according to the Guardian. "There is a lot of focus now on trying to get very quick pay-offs in research. It is a huge mistake. Basic science has paid off far more than any directed research," he says. "If you don't invest properly in fundamental science, then you won't have the foundations to develop the technologies and applications of tomorrow. Ten years down the line, your technology will be based on obsolete foundations."

Congress Encouraged to Continue Senator Kennedy's Legacy of Supporting Stem Cell Research & Development

OLDSMAR, Fla., Sept. 29 /PRNewswire-FirstCall/ -- Mercedes Walton, CEO of Cryo-Cell International, a global leader in stem cell innovation, reflects with gratitude on the late Senator Ted Kennedy's legacy of championing initiatives for improving the health and well-being of all Americans, and with hope for the future that the momentum will continue.

Senator Kennedy's commitment to keeping the United States at the forefront of health research and innovation is far-reaching and affects many different aspects of health and human services around the country. One area in particular which experienced great strides during Senator Kennedy's 47-year Senate tenure was the field of stem cell research and development aimed to diagnose and treat diseases. Thanks in part to his passionate support, stem cells from umbilical cord treat more than 75 diseases today, including sickle cell disease, several types of acute and chronic leukemias, Non-Hodgkin's lymphoma, and Hodgkin's disease. Emerging science shows great promise for potential treatments including spinal cord injury, heart disease, breast cancer, stroke, diabetes, Parkinson's disease, Alzheimer's disease and many more.

Among the many examples of Senator Kennedy's commitment to biomedical research include his sponsorship of the National Institutes of Health Revitalization Act of 1993 and its reauthorization in 2003. These acts provided resources and funding for medical research. The NIH reports that there are more than 2,700 clinical trials underway today which utilize stem cells in some way.

Another example is Senator Kennedy's strong support of the Hematological Cancer Investment Research and Education Act of 2001. This bill increased research and education on blood cancers, including leukemia, lymphoma, and multiple myeloma. Today, stem cells from cord blood treat several of these types of cancers, including four types of acute leukemias and four types of chronic leukemias.

Regarding stem cell research, Senator Kennedy said in his statement opening the 110th Congress:

"The debate on stem cells touches the spirit of every [sic] Americans because it's about hope. Hope is what stem cell research means to millions of Americans who seek better treatments and better drugs for cancer, diabetes, spinal injury, and many other serious [sic] illness. In this new century of the life sciences, we see benefits of discovery all around us. Leading scientists agree that the potential of stem cell research is extraordinary. We should stop delaying the hope and the help that stem cell research can bring."

While much of the debate and controversy surrounding stem cell research focuses on embryonic stem cells, the community which leverages less controversial stem cells - such as those from umbilical cord blood and even menstrual blood - benefits nonetheless. These areas are able to make great progress as a result of the ongoing discoveries and developments across the stem cell arena.

"Senator Kennedy was a true champion of all causes related to human rights, civil rights, and protecting the environment," said Walton. "I encourage our nation's lawmakers to keep firmly in their sights and their priorities the issues related to stem cell research and development, including H.R. 1718 and H.R. 2107," she added.

H.R. 1718, the "Family Cord Blood Banking Act," and H.R. 2107, the "Cord Blood Education and Awareness Act of 2009" would enable and promote continued research, public awareness and tax benefits related to storing and using cord blood.

"It is important that these initiatives be reinvigorated and passed, to help ensure that Americans have information and incentive to harness the potential miracles that stem cells offer," said Walton.

A pioneer in the non-controversial stem cell arena, Cryo-Cell has served nearly 185,000 clients worldwide and led the cord blood banking industry with the successful establishment of a state-of-the-art Good Manufacturing Practice/Good Tissue Practice (cGMP/cGTP) laboratory processing facility well ahead of emerging regulation and competition.

Stemedica Requests Pre-IND Meeting With FDA

Stemedica Cell Technologies, Inc. USA, a leader in adult stem cell research and manufacturing, has requested a pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration ("FDA") to discuss a proposed IND to use Stemedica's proprietary line of allogeneic mesenchymal bone marrow cells (adult human) as a treatment for ischemic stroke.

Stroke is a leading cause of adult impairment, with 20% of stroke survivors requiring institutional care after 3 months and up to 30% severely and permanently disabled. The only approved treatments of acute ischemic stroke involves restoring blood flow to the affected region by using thrombolytics or mechanical devices that physically remove clots. However, the use of thrombolytics (tPA) is limited due to the therapeutic window of < 3-6 hours post onset of stroke symptoms such that only a small fraction of stroke patients receive this therapy.

"Following a stroke, there is little therapy to offer patients to promote recovery other than physical, occupational, and speech therapy," said Nikolai Tankovich, MD, PhD, President & Chief Medical Officer. "Treatment with allogeneic mesenchymal bone marrow cells may offer new hope to patients with chronic neurological or age-related, neurodegenerative diseases."

Allogeneic mesenchymal bone marrow cells are obtained from donors by extracting bone marrow and are expanded at Stemedica's cGMP compliant facility, which is licensed by the California Department of Public Health, Food and Drug Branch. "Stemedica's facility will manufacture clinical grade stem cells as it prepares for FDA approval of an IND to begin clinical trials," said Maynard Howe, PhD, Vice Chairman and CEO of Stemedica.

About Stemedica Cell Technologies, Inc.

Stemedica Cell Technologies Inc. is a specialty biopharmaceutical company that is committed to the development and manufacturing of best-in-class adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and human clinical trials. The company is currently developing regulatory pathways for stroke and wound repair. Stemedica is headquartered in San Diego, California.

Source: Stemedica Cell Technologies, Inc

U.S. stem cell research seems to focus on two lines

FRIDAY, Aug. 7 (HealthDay News) -- Only two of 21 approved human embryonic stem cell lines are routinely used by researchers in the United States, says a new study.

The study found that two cell lines, known as H1 and H9, accounted for 941 of 1,217 requests, or 77 percent, placed by scientists since 1999 for human embryonic stem cell lines housed at the two largest stem cell banks in the country.

Another line, H7, was requested 111 times, and 13 other lines were requested fewer than 10 times.

The study's authors also found that H9 was discussed in 83 percent of 534 published studies from 1999 to 2008, H1 was discussed in 61 percent and H7 in 24 percent. The total is more than 100 percent because many studies used more than one cell line.

"I was surprised by the results," Christopher Scott, director of Stanford University's Program on Stem Cells in Society, said in a news release. "I never imagined that we would find that three-fourths of the requests would be for the same two cell lines."

The study appears in the Aug. 7 issue of Nature Biotechnology.

Scott and his fellow researchers said the findings raise concerns about the reauthorization process of stem cell lines under way at the U.S. National Institutes of Health. If the lines that have been in use are excluded from federal funding because of ethical considerations, they said, scientists might abandon research on them in favor of other cell lines.

However, they added, the two most-used lines might have abnormalities or other characteristics that would make them less useful than newer lines.

Future NIH policies should preserve scientists' ability to continue work on the well-studied lines while also encouraging the study of new lines expected to become eligible for federal funding, Scott said.

More information
The U.S. National Institutes of Health has more about stem cells.-- Robert Preidt

SOURCE: Stanford University, news release, Aug. 7, 2009
Copyright © 2009 ScoutNews, LLC. All rights reserved.

Group Hustles to Keep Stem Cell Center on Schedule

By Tom Fudge
August 11, 2009

SAN DIEGO — San Diego's Sanford Consortium for Regenerative Medicine is working to meet a Thursday deadline for a major loan on it's research center. The center will be the most visible benefit to San Diego of Prop 71, which funds stem cell research.

Workers build a mock-up of the research center that will house stem cell scientists from four San Diego research institutes Salk, Burnham, Scripps and UCSD. The stem cell center will be across the street from the Salk Institute and just inland from the coastal glider port. Louis Coffman is vice president of the Sanford Consortium.

"Total cost to build is $110 million," he said. "And then for special equipment for some of the core facilities is another $15 million... so $125 million total."

Backers of the building say putting top local stem cell scientists in the same building will create a critical mass of knowledge.

"We like to say the ability to collaborate is inversely proportional to the square of the distance that separates you," said Dr. Edward Holmes, the CEO of the Sanford Consortium. "By having these people all in one building where the post-doctoral fellows, the graduate students, the senior scientists are all drinking from the same coffee machine and exchanging ideas on a daily basis, it really does facilitate the discovery process."

Stem cells can be used to regenerate degenerative tissues, among other uses. San Diegans hope the stem cell research center will generate economic activity as commercial operations spin off of it. Holmes says he expects shovels to go in the ground next month, and the center to be finished in 2011.

Living cells controlled with light; potential for stem cell research

University of Central Florida researchers have shown for the first time that light energy can gently guide and change the orientation of living cells within lab cultures. That ability to optically steer cells could be a major step in harnessing the healing power of stem cells and guiding them to areas of the body that need help.

The results, presented at the 2009 Conference on Lasers and Electro-Optics/International Quantum Electronics Conference, were discovered by a research team led by Aristide Dogariu, an optical scientist at the College of Optics and Photonics, and Kiminobu Sugaya, a stem cell researcher at the College of Medicine's Burnett School of Biomedical Sciences.

Long-term implications of the work include stimulating and controlling tissue regeneration for cleaner wound healing and the possibility of altering the shapes of cells and preventing malignant tumors from spreading throughout the body.

While optical techniques such as drilling microscopic holes with light or using the light as tweezers have shown promise in manipulating small pieces of matter, the UCF team explored the use of a gentler light energy. Their work showed for the first time that optically induced torques can affect components within cells that drive their motility -- their ability to move spontaneously -- and change the orientation of cells within cultures.

While earlier studies of cell manipulation have emphasized shielding the cell from the power of the light, Dogariu and Sugaya focused on using that energy to stimulate the cells' natural tendencies.

Living cells use energy to move actively and spontaneously. To influence them without jeopardizing their chemical makeup was a tremendous challenge. Dogariu and Sugaya began exploring the idea of moving an entire cell by focusing on its inner mechanisms. Inside the cells there are slender rods made up of a protein called actin.

"Actin rods are constantly vibrating, causing the cells to move sporadically" Sugaya said. The researchers demonstrated that low-intensity polarized light can guide the rods' Brownian motion to ever-so-slowly line up and move in the desired direction.

"Stronger light would simply kill them," Dogariu said. "We wanted to gently help the cells do their job the way they know how to do it."

A time-lapse video shows that after more than two hours of exposure to light with specific characteristics, a group of stem cells migrates from a seemingly random mix of shapes, movement and sizes to a uniform lineup.

http://www.ucf.edu

Nebraska Schools To Research non-Embryonic Stem Cells

Three universities in Nebraska have received a total of $900,000 from the state to fund non-embryonic stem-cell research.

The University of Nebraska Medical Center will receive half the money for three separate projects, including a study of how non-embryonic stem cells might help people with Parkinson's disease.

Creighton University School of Medicine was awarded $300,000, and the University of Nebraska-Lincoln received $150,000.

Non-embryonic stem-cell research doesn't usually generate research because embryos are not destroyed.

The money comes from Nebraska's cut of the national settlement with tobacco companies.

The grants were authorized by a law passed by the Nebraska Legislature last year.

2 Chinese teams break new ground in stem cell research

Live mice created from cells derived from skin tissue

WASHINGTON: Two teams of Chinese scientists have made a major advance in mice in the development of a new kind of stem cell that does not involve destroying embryos.

These cells are derived from ordinary skin cells, and were hailed as a breakthrough when they were created two years ago from human skin and genetically reprogrammed. But questions remained on whether they could act as chameleon-like as embryonic stem cells and morph into any cell type in the body.

One way to show that versatility was if the new reprogrammed stem cells could be used to produce an entire new life. And now researchers have shown that they can, in mice.

For the first time, they were able to produce live mice from stem cells that were coaxed from the skin tissue of adult mice and then reprogrammed. While there were abnormalities and unusual deaths with some of the first generation of mice, one team produced enough normal mice through this method to create hundreds of second and third generation mice.

Studies on this type of stem cell, called iPS for induced pluripotent stem cells, were released on Thursday by two competing scientific journals, Nature and Cell Stem Cell.

“We demonstrated the practicality of using iPS cells,” said Fanyi Zeng, associate director of the Shanghai Institute of Medical Genetics and co-author of the larger, more successful study which appears in Nature.

Dr. George Daley of the Harvard Stem Cell Institute and Children’s Hospital of Boston, a leading U.S. stem cell researcher who was not part of either study, hailed the work as important because it shows that the new type of stem cells “satisfy the most stringent criteria of embryonic stem cells — the ability to make a mouse entirely from cells in a petri dish.”

Less controversy

These stem cells generate less controversy than embryonic stem cells, which scientists have been studying for more than a decade. Embryonic stem cells involve the destruction of embryos, usually excess from fertility clinics.

The new type of stem cells uses a virus to reprogramme the genetic information of the skin cell to make it a stem cell. Because it cannot create a placenta, the Chinese researchers had to then combine the new stem cell with cells that provide a placenta.

Dr. Zeng said all types of stem cell research should continue, not just the new type. Her study produced 27 live mice, some of which had “abnormalities.” However, she declined on adding what those were or how extensive the problems were. “That will be in a future report,” she said. The 27 mice produced second and third generations that included hundreds of mice with no noticeable abnormalities.

The other team of scientists got only four births — three died quickly and only one made it into normal adulthood.

“Unethical for humans”

“We are confident that tremendous good can come from demonstrating the versatility of reprogrammed cells in mice,” Dr. Zeng said in an e-mail, adding that while this is just in mice, it could help doctors “understand the root causes of disease and lead to viable treatments and cures of human afflictions.”

Dr. Daley and Dr. Zeng noted that the process is not very efficient — many attempts were required to get stem cell generated births. — AP

Coalition opposes embryonic stem cell research

The North Platte Telegraph

The Nebraska Coalition for Ethical Research believes in stem cell research.

What is often misunderstood is that there are two types of stem cell research. Adult stem cell research has produced treatment and cures for 73 conditions, including several types of cancer and leukemia, autoimmune diseases such as sickle cell anemia and multiple sclerosis, spinal cord injuries and heart damage. The second type of stem cell research is embryonic, which harvests stem cells from a recently fertilized cluster of cells, usually within the first five days after fertilization, destroying the embryo.

On March 9, President Barack Obama announced he was ordering the National Institute of Health to revise the guidelines for federal funding to expand to include embryonic stem cell research. Those guidelines are expected to be published in the next few weeks. Immediately following the president's announcement, the University of Nebraska Medical Center announced they intended to pursue federal money for embryonic stem cell research.

The Coalition is urging the University of Nebraska Board of Regents to leave restrictions on embryonic stem cell research in place.

"We love stem cell research," said NCER executive director Chip Maxwell. "However, all breakthroughs in stem cell research are the result of research in non-embryonic stem cells."

There have been no clinical trials using embryonic stem cells in humans, Maxwell said.

"The FDA approved the first clinical trial in January of this year," Maxwell said. "Stem cell research was thriving before we started messing around with embryonic cells."

NCER president Dr. Sheryl Pitner joined Maxwell along with NCER deputy director Justin Nabity and advisory board member Charles Brockhouse, Ph.D., geneticist at Creighton University in North Platte Monday evening for a pro-life meeting. More than 70 people heard Maxwell outline NCER's opposition to embryonic stem cell research.

Regent Bob Phares told the crowd that while he is personally opposed to expanding research at UNMC for embryonic stem cell research, the board has a policy in place to follow federal guidelines.

"When the revised guidelines come out in early July, we will lay them next to the old ones and see where we are," Phares said.

Nebraska state law prohibits the use of embryonic stem cells for research in state facilities and the use of state funding for research.

"We are going to follow the law," Phares said.

The federal policy change will result in an increased demand for the destruction of human embryos Maxwell said, something that is unethical and unnecessary, given the positive results of adult stem cell research.

"We are a secular group," Maxwell said. "Our goal is to raise the Regents comfort level to the point where they do not allow the destruction of embryos at UNMC."

NCER's opposition to embryonic stem cell research is based in science, Maxwell said.

"Any genetic textbook will tell you that the moment fertilization is complete, the genetic code of that cell is complete," Maxwell said. "From that first cell to death, you are a human being."

Destruction of embryos is a matter of destroying one human to help another, he said.

"Embryonic stem cell research is high tech exploitation of the vulnerable by the strong," Maxwell said.

The perception that adult stem cell research is merely a poor substitute for embryonic stem cell research needs to be flipped, Maxwell said.

"We want to contain embryonic stem cell research right where it is," Maxwell said.

NCER is seeking signatures on a petition urging the Regents to keep the restrictions on embryonic stem cell research in place. The petition is available on line at the groups Web site, www.ethicalresearch.net. For those who do not have access to the Web site, call (402) 690-2299 to have a copy of the petition sent to you.

Vatican steps back on praise for Obama

VATICAN CITY -- The official Vatican newspaper emphatically denied that its friendly coverage of President Barack Obama reflects any tolerance of his support for legalized abortion and embryonic stem cell research.

"In reporting on some recent statements and initiatives of the president of the United States, L'Osservatore Romano certainly did not intend to express appreciation for his positions on ethical questions," said an unsigned article in the paper's Friday (June 5) edition.

"Obviously the Holy See and L'Osservatore Romano have been, are, and will be standing side by side with the bishops of the United States in their commitment to the inviolability of human life in whatever stage of its existence."

Known as the "pope's newspaper," L'Osservatore is under the direct authority of the Secretariat of State, which directs the Vatican's diplomatic relations, and reportedly vets articles on sensitive topics before publication.

The paper's coverage of Obama has been consistently friendly, and at times openly enthusiastic, since his election last November.

Rabbi to speak on stem cell research

“Religious Perspectives on Stem Cell Research” will be discussed by Rabbi Dennis S. Ross, director of Concerned Clergy for Choice, at 7 p.m. Wednesday at Temple Concord, 9 Riverside Drive, Binghamton.

The program, sponsored by the Temple Concord Social Action Committee, is free and open to the public.

“People facing diabetes, Parkinson’s disease, spinal cord injury and other life-threatening and life-altering medical conditions turn to stem cell research with hope for a cure,” Ross said.

Concerned Clergy for Choice is a statewide, multi-faith network of 1,000 religious leaders who support access to reproductive health care and education. The Albany-based network is a project of Family Planning Advocates of New York State.

New Stem Cell Web Site to Focus on Traumatic Brain Injury, Spinal Cord Injury and Diabetes

SAN DIEGO, May 28 /PRNewswire/ -- Entest BioMedical, Inc., a newly formed wholly-owned subsidiary of San Diego-based Bio-Matrix Scientific Group, Inc. (OTC Bulletin Board: BMSN - News) announced today the launch of its Web site (http://www.EntestBio.com) to focus on new stem cell research, including a proposed research to develop a new therapeutic solution for traumatic brain injury (TBI) using autologous adipose-derived (fat) stem cells representing a potential cure. There are currently 1.5 million new cases of TBI occurring in the U.S. each year, adding to the almost 6.5 million existing cases. The Company is also pursuing research in the use of fat stem cell therapy for spinal cord injury, in which approximately 200,000 patients in the U.S. suffer from this disability.

The site also highlights the Company's progress in developing a gestational diabetes screening test, as the exclusive licensee granted by UCLA. The non-invasive, highly accurate streamline test mitigates the lengthy process of diagnoses and would more quickly treat the glucose intolerant disease, which potentially impacts 4.3 million pregnant women each year.

Along with background about types of stem cells and factoids, the new site also reviews Entest BioMedical's focus on the promising field of in vitro expansion of adult stem cells using other types of cells, such as peripheral stem cells and cord blood stem cells to treat cancer and other diseases. The R & D company is also exploring isolating hematopoietic stem cells from peripheral blood or bone marrow and differentiating them into immune cells, especially T cells.

"Our new Web site demonstrates Entest BioMedical's mission and key scientific personnel who are dedicated to discovering and developing new procedures, treatments and medical devices that improve the quality of life - leading research and technology that serve the present and help shape the future," said David Koos, Ph.D., DBA, Chairman and CEO.

About Entest BioMedical, Inc.

Entest BioMedical, Inc., a wholly-owned subsidiary of Bio-Matrix Scientific Group, Inc. (OTC BB: BMSN - News) formed in April 2009, focuses on research and development of traumatic brain injury (TBI) and spinal cord injury using autologous "adipose-derived" stem cells. Entest BioMedical is involved with R&D activities relating to stem cell therapies, diabetes testing and medical devices.

Disclaimer

This news release may contain forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements. The risks and uncertainties to which forward-looking statements are subject include, but are not limited to, the effect of government regulation, competition and other material risks.

New Stem Cell Research Unlocks Unknown Therapies

"Stem cell research and regenerative medicine are in an extremely exciting phase right now. We are gaining knowledge very fast and many companies are being formed and are starting clinical trials in different areas," says Dr Jonas Frisén.

As an example, a first-in-human study was just initiated for Parkinson's disease patients with the drug product, sNN0031, from the Swedish company NeuroNova. The drug, which is administered into the fluid-filled cavities of the brain, has shown long lasting recovery and formation of new cells in animal models of Parkinson's disease. Last year, a treatment for ALS entered the clinical trial phase.

Disorders in the brain and nervous system result in more hospitalizations than any other disease group, and treatments entail large costs to society. The research field of neuroscience is one of Sweden's finest. This had resulted in achievements within numerous areas of basic science with considerable scope to direct clinical applications. These include research advances concerning the origin and repair of nerve cell damage following stroke and spinal cord injury, as well as research into major degenerative diseases such as Parkinson's and Alzheimer's.

Dr Frisén is one of Sweden's leading stem cell researchers, since many years with a focus on nerve stem cells. Among his most recent publications is an article in Science, April 3rd, 2009 where evidence is shown for renewal of heart muscle cells in humans, a result that can be used to develop therapeutic strategies for cardiac pathologies.

NeuroNova AB is a Swedish biopharmaceutical company working with neurogenesis and neuroprotection for treatment of several currently incurable neurodegenerative diseases. Dr Jonas Frisén is the scientific founder of NeuroNova.

Source:
Sabina Bossi
Karolinska Institutet

Obama Judicial Nominee Draws Opposition From Disability Community - Judge Andre Davis' Record Reveals Bias Against Workers with Disabilities

Contact: Jim Ward, President
ADA Watch/National Coalition for Disability Rights (NCDR)
Washington, DC
www.adawatch.org

A national nonpartisan coalition of disability, civil rights and social justice organizations today announced their opposition to the confirmation of Judge Andre Davis, President Obama's pick for a lifetime seat on the United States Court of Appeals for the Fourth Circuit.

ADA Watch and the National Coalition for Disability Rights (NCDR) are opposing Davis because his record as a district court judge in Maryland reveals a bias against workers with disabilities. The group stated that the Americans with Disabilities Act (ADA) is critical to the efforts of people with disabilities to obtain and maintain employment and to become fully participating members of their communities.

The organization's president, Jim Ward joined other leaders at the White House last week and informed the Administration of their opposition. Ward stated today, "The current leadership in Congress and the White House have promised to select judicial nominees who understand the challenges facing working Americans and who are committed to core value of equal justice. We believe that in the area of disability rights this nominee's record does not meet these baseline criteria and, therefore, we are opposed to Judge Davis's elevation to the Fourth Circuit and will mobilize our membership in this regard."

·   Judge Davis has repeatedly imposed inappropriately stringent standards that have prevented individuals with disabilities from enforcing rights under federal antidiscrimination laws, particularly in the area of employment.

·   He has made it exceedingly difficult for people to show that they are individuals with disabilities entitled to the protections that Congress provided in the ADA.

·   He has incorrectly imposed procedural hurdles on ADA plaintiffs that are contrary to the ADA's requirements.

·   He has applied cramped interpretations of law to reject the discrimination claims of workers with disabilities.

ADA Watch is a national, cross-disability coalition of hundreds of disability, civil rights and social justice organizations united to defend and advance the civil rights of people with disabilities. The National Coalition for Disability Rights (NCDR) is the national association of state disability coalitions. For nearly a decade, ADA Watch/NCDR's Campaign for Fair Judges has informed the disability community and the general public regarding judicial nominees that pose a threat, based on their public records, to civil rights protections under the Americans with Disabilities Act (ADA) and other disability rights laws. While not all of our national and state coalition partners take positions on judicial nominees or share this position, a majority of our Board of Directors has voted to formally oppose the confirmation of Judge Davis.

Excerpts from letter to White House with legal research and analysis by the Bazelon Center for Mental Health Law:

The White House has asserted that Judge Davis has a very balanced track record in disability cases. We appreciate that Judge Davis has reached decisions favorable to the plaintiffs in cases involving issues such as physical access to courthouses and housing developments, and effective communications with medical providers. These cases do not, however, assuage our concerns about Judge Davis's record in the area of employment discrimination, in which people with disabilities fare particularly poorly.[1] It is in that context that the vast majority of disability discrimination cases are brought. As such, it is in that context that we are particularly concerned with ensuring that our judges respect the civil rights of individuals with disabilities.

We could find only one published decision, in nearly 14 years on the bench, in which Judge Davis ruled in favor of the plaintiff on the substance of an Americans with Disabilities Act (ADA) employment discrimination claim.[2] A number of the decisions in which he ruled for the employer are deeply troubling in ways that relate to core disability community concerns:

In Rose v. Home Depot U.S.A., Inc., 186 F. Supp.2d 595 (D. Md. 2002), Judge Davis set out extraordinary hurdles for a person to demonstrate that he had a disability. The judge refused to recognize Gary Rose's disability because he "did not follow the proper protocol in determining whether he had vasomotor rhinitis" and "did not receive a proper treatment plan for his impairment." Nothing in the ADA requires a person to have a proper diagnosis or a treatment plan in place for his disability in order to receive protection from discrimination. Judge Davis, however, found that Rose should have followed up with a different doctor, undergone a CT scan to rule out the possibility of a different diagnosis, and "consistently followed a treatment regime" in order to establish his disability. This type of analysis is particularly problematic for individuals with disabilities that are challenging to diagnose accurately and treat effectively, including many individuals with
psychiatric disabilities. The notion that individuals should be denied protection under the ADA until they have spent months or years trying to obtain effective treatment to control the effects of their disabilities is a perversion of the ADA, and is certainly not suggested by the decisions of either the Supreme Court or the Fourth Circuit.[3]

In Fitch v. Solipsys Corp., 94 F. Supp.2d 670 (D. Md. 2000), Judge Davis held that the ADA's "regarded as" prong did not protect someone who is repeatedly referred to as a "cripple" by his employer.    Keith Fitch presented evidence that he was referred to by his employer as a "cripple" on multiple occasions due to a heart condition that limited him from lifting more than forty pounds. Judge Davis concluded that this was not sufficient to show that he was regarded as disabled in the context of a work environment where "employees regularly used derogatory nicknames for each other."
·    In Martell v. Sparrow's Point Scrap Processing, LLC, 214 F. Supp.2d 527 (D. Md. 2002), Judge Davis held that the "regarded as" prong did not protect someone who is denied a job, even though the employer did not hire the applicant precisely because of his "abnormal hearing." Robert Martell presented evidence that he was regarded as substantially limited in hearing and working when an employer withdrew a job offer after learning that he had a hearing impairment, even though his hearing aids allowed him to recover "virtually all of his auditory capacity." In a holding not required by Fourth Circuit authority, Judge Davis found that Martell was not regarded as substantially limited in either hearing or working, even though the employer explicitly admitted that it refused to hire Martell because it believed that his "abnormal hearing" would create a danger in a noisy industrial setting.

·    In Campbell v. Federal Express Corp., 918 F. Supp. 912 (D. Md. 1996), the plaintiff, an applicant for a courier position whose left hand had been injured and lacked flexion, did not challenge Federal Express's refusal to hire him with the federal Department of Transportation.    Judge Davis held that the ADA requires a person bringing an employment claim under the ADA to exhaust an administrative review process with another agency, in this case the DOT, in addition to the Equal Employment Opportunity Commission (EEOC) where an employer relies on that agency's regulations to support its defense. There is no requirement in the ADA or its regulations that plaintiffs in employment discrimination cases do so, only that they first seek relief from the EEOC before filing in federal court.

·    Finally, Judge Davis requires even pro se ADA litigants to overcome significant hurdles in exhausting their claims before filing. In Walton v. Guidant Sales Corp., 417 F. Supp.2d 719 (D. Md. 2006), Judge Davis dismissed the disability employment discrimination claim of a pro se plaintiff for failure to exhaust administrative remedies. Judge Davis ruled that, even though the EEOC itself considered the plaintiff to have filed a sufficient administrative charge within the statute of limitations, he had not. Judge Davis also ruled that equitable tolling should not apply. Equitable tolling applies when a pro se plaintiff misses a charge filing deadline due to reliance on misleading or incorrect information from the EEOC. Judge Davis held that the plaintiff here had not met this standard even though the plaintiff had contacted the EEOC on numerous occasions to inquire about the status of his administrative charge, was initially sent the wrong form by the EEOC,
alleged that he timely filed the corrected form that he was sent after informing the EEOC of their mistake, and was helped by the EEOC to complete another charge after the deadline because they could not find his earlier form and had experienced problems with their data management system during the relevant time period.

These holdings demonstrate a troubling misunderstanding of Congress's intent that the ADA offer significant protections from discrimination to millions of workers with disabilities. Our concern is not diminished by the enactment last year of the ADAAA, which restored the ADA's definition of disability to the broad scope intended by Congress and wrongfully restricted by decisions such as Judge Davis's.    These decisions, erroneously decided as they are, leave us fearful that Judge Davis may similarly misinterpret last year's amendments.

The selection of judicial nominees is extraordinarily important to our community given the serious obstacles that individuals with disabilities have faced in trying to enforce their rights in the courts, particularly in the context of workplace discrimination. The Fourth Circuit is of foremost concern to us, since that court is now closely split and in recent years has decided many significant disability rights decisions by divided panels. More than any other circuit, the Fourth Circuit has the potential to undergo significant balance-shifting when its vacant seats are filled.

The ADA's protections are critical to the efforts of people with disabilities to obtain and maintain employment and to become independent and fully participating members of their communities. We are very concerned that Judge Davis's elevation to the Fourth Circuit will do little to ensure that their rights are protected. We hope that you will recognize that and will take seriously the concerns of people with disabilities in the Judiciary Committee's consideration of Judge Davis's nomination.

Obama's Embryonic Stem Research Proposal Not Bold Enough, New York Times Editorial Says

Although the Obama administration's announcement of draft guidelines for federal funding of embryonic stem cell research "is a significant improvement" over former President George W. Bush's more restrictive policy, the new proposal "is not bold enough and will continue to deny federal financing to some potentially promising research," a New York Times editorial states. The Times reports that Obama’s proposal would allow federal funding "only on stem cell lines created from surplus embryos at fertility clinics but not on lines created in the laboratory to study particular diseases." Still, unlike Bush's restrictions, Obama's proposal would allow federally financed researchers to study embryonic stem cell lines that might be created in the future, the editorial says. In addition, it could "significantly expand the number of past lines that can be studied with federal dollars to include some of the hundreds that have been created around the world from surplus embryos," according to the editorial.

It continues that the new guidelines propose "rigorous eligibility standards," including that individuals who wish to donate surplus embryos from fertility treatments be informed of all disposal options, that written consent is obtained separately from donors' decision to create the embryos and that donors are permitted to withdraw consent before the embryos are used. These requirements are "widely accepted today," but "they could rule out research on lines derived in the past under less stringent codes, including many created at leading universities or even those approved under Mr. Bush," according to the editorial. "Officials will need to pay close attention to this potential problem before issuing final guidelines," the editorial says. The editorial also notes that the National Academy of Sciences and other scientific organizations have endorsed research using lab-created embryos to genetically match treatments for patients with certain diseases, such as diabetes or Parkinson’s. The guidelines would prohibit such research, known as "therapeutic cloning," although scientists have not yet successfully produced such embryos.

"The guidelines seem likely to increase the amount of embryonic stem cell research supported by the government without triggering a political backlash," the editorial says, concluding, "But given the potential value of the science, it is disappointing that the NIH didn't go further" (New York Times, 4/23).

Reprinted with kind permission from http://www.nationalpartnership.org. You can view the entire Daily Women's Health Policy Report, search the archives, or sign up for email delivery here. The Daily Women's Health Policy Report is a free service of the National Partnership for Women & Families, published by The Advisory Board Company.

New Method For Bone-marrow-derived Liver Stem Cells Isolation And Proliferation

Bone-marrow-derived liver stem cells were once a hot topic in the field of stem cell research because of their important therapeutic implications, but little progress has been made in recent years because of the difficulty of isolation and proliferation of this special cell population. A research group in China has provided a new method for BDLSC isolation and proliferation, which brings new hope to the clinical use of bone-marrow-derived stem cells.

Great interest has been aroused in the identification and isolation of liver stem cells from bone marrow cells. Several subsets of bone marrow cells have been found to have the potential to differentiate into hepatocytes, however, sorting based on immunological methods is difficult because of the complicated surface markers of the stem cells; furthermore, no report of successful passage has been published.

A research team led by Dr. Cai and his colleagues from the Affiliated Foshan Hospital and the Second Affiliated Hospital of Sun Yat-sen University established a carefully designed culture system to isolate, proliferate and differentiate liver stem cells directly from bone marrow cells, and they were able to achieve six passages of the stem cells. The results suggest that BDLSCs can be purified and passaged.

The selecting culture system that contains cholestatic serum can purify BDLSCs directly from bone marrow cells, which provides an easy method to separate stem cells, by avoiding complicated immunological manipulation. The successful passage of the stem cells further verifies the proliferating ability of the cells, although the passage is limited, and further research will provide more experience.

In this study, the authors used their original method to retrieve the cells, which are possibly BDLSCs. Then, they used fluorescence-activated cell sorting to determine the cells' characteristics before and after differentiation. This is an interesting and potentially important study, which suggests that bone-marrow-derived cells can be stimulated to expand and then differentiate into hepatocyte-like cells, which can possibly be used to treat liver disease.

Meeting with Congress UCI scientist will visit Capitol Hill to share plans he has with other researchers regarding stem-cell treatments.

By Joseph Serna

A leading neuroscientist and co-director of UCI’s stem cell research center will meet with members of Congress today and explain what he and his team will do when they conduct the first human trials of stem-cell therapy in the country later this year, university officials said.

Hans Keirstead, co-director of the Sue and Bill Gross Stem Cell Research Center and faculty member at the Reeve-Irvine Research Center, will meet with members of Congress and their aides to explain how he plans to implement his success spinal-cord injury therapy to humans. Keirstead’s clinical trials were recently approved by the Food and Drug Administration and will be the first human trials in the country.

Palo-Alto-based Geron Corp. will run the trials.

It’s basically an informational meeting where he will meet government officials and explain to them what he’s doing, so they can go back to their colleagues and update them, company officials said.

Keirstead will join Geron president Thomas Okarma and spinal-cord-injury research advocate Robert Klein on Capitol Hill from 10 to 11:30 a.m. today. The prominent neuroscientist is also expected to meet individually with policy- and lawmakers and emphasize the importance of academia partnering with industry for advances in medicine.

Keirstead will brief congressional members on his treatment of methylprednisolone, a type of paralysis. In a lab setting, he and UCI researchers have successfully restored motion for mice when they inject stem cells into the injured mouse’s spine within hours of the injury.

Paralysis can occur when the electrical signal from the brain through the Central Nervous System, notably through the spine, is stopped, such as during an injury. In Keirstead’s therapy, stem cells are injected into the injured area and replace the disrupted nerves, restoring the electrical signal, before scar tissue can form there and make the injuries permanent.

“If we can restore the ability for a quadriplegic to move his thumb, I would be dancing around,” Keirstead said earlier this year about the research.

What are the next steps for embryonic stem cell research?

A new report on embryonic stem cell research from The George Washington University School of Public Health and Health Services (SPHHS) reviews key issues likely to be debated in the coming months as Congress and the National Institutes of Health (NIH) determine how the research will move forward.

President Barack Obama signed an executive order lifting the ban on federal funding for embryonic stem cell research on March 9, and asked the NIH to revise its existing guidelines within 120 days. While these steps alone will undoubtedly expand research significantly, choices made in Congress and at the NIH could promote further research activity, or change its direction.

According to the report, Congress could codify the President's action - or countermand it - so that it could not be as readily altered by future administrations. Legislators also could overturn existing laws so that federal funding can be used not only to study any available stem cell lines, but also to create new ones. Likewise, the NIH has substantial leeway in deciding whether to support research that uses so-called "custom-made" embryos created exclusively for research, or derived through the techniques of therapeutic cloning, or to limit its support to embryos created at in-vitro fertilization clinics.

This paper describes pending legislation and existing guidelines designed to promote responsible research practices in the field of embryonic stem cell research, while explaining the decisions still to be made at the federal level

Stem cell expert coming to UNCC

One of the world's renowned experts on stem cell research is speaking next Tuesday at UNC Charlotte, and the lecture is open to the public.

Irving Weissman, from the Stanford Institute of Stem Cell Biology and Regenerative Medicine, will speak at 10:30 a.m. next Tuesday in the Barnhardt Student Activity Center Salons.

Admission to the speech is open to the public, at no charge. But registration is required, and the deadline is Friday.

Weissman developed the general method to identify and isolate stem cells. Using that method, he and his collaborators developed the potential to isolate and harvest and stem cell from any tissue in any species. He also co-discovered a human central nervous system stem cell.

His current research encompasses the biology and evolution of stem cells, and he also is working to isolate and characterize cancer stem cells from a wide variety of solid tumors and leukemia.

The topic of his speech will be "Stem Cell Research and Public Policy."

UConn stem-cell research gets state-funded grant awards

By SCOTT WHIPPLE
Staff writer

Stem-cell research got a vote of confidence this week from state-funded grant awards; in fact, some researchers believe these awards will move research findings from the laboratory to the clinic.

Eleven University of Connecticut scientists received awards totaling $5.4 million from the Connecticut Stem Cell Research Advisory Committee. The awards are expected to advance embryonic and human adult stem-cell research in Connecticut.

Nine of the state grants were awarded to scientists at the University of Connecticut Health Center in Farmington and two to researchers based at UConn’s Storrs campus. A total of 24 projects were awarded nearly $9.8 million.

In 2005 the Bush administration banned federal funding for human embryonic stem-cell research. However, when President Barack Obama lifted the ban, Connecticut scientists were optimistic that state funding would eventually enable them to qualify for federal research funds.

“These grants are further testament to the ground-breaking work in stem-cell research going on at UConn’s Health Center and Storrs campuses,” said University of Connecticut President Michael Hogan. “This further investment by the state in our stem-cell programs reflects the leadership role UConn researchers are playing in scientific discovery and state-of-the-art health care. I’m very proud of the work of our research teams.”

The funding program, approved by the legislature and Gov. M. Jodi Rell in 2005, set aside $100 million for Connecticut-based embryonic and adult stem-cell research through 2015. Stem cells are the “building blocks” for every kind of cell in the body, capable of maturing into any tissue type, including pancreas, blood, bone or neuronal cells. Research on stem cells holds the promise of advancing human health care by developing cell transplantation therapies for diabetes, cancers, heart and blood diseases, Parkinson’s, multiple sclerosis and Alzheimer’s diseases.

The state committee disbursed $20 million for 21 stem-cell training-and-research programs at UConn and other Connecticut universities in 2006. In 2008, another 22 research proposals were awarded nearly $9.8 million.

For this year’s third round, the committee received 77 preliminary requests seeking more than $30 million for research projects. UConn and its Health Center submitted 41 of the research proposals; Yale University turned in 30. Wesleyan University, the University of Hartford and Western Connecticut State University each submitted one proposal, as did two small biotech firms based in the state.

UConn Health Center Genetics and Developmental Biology Professor Ren-He Xu, received the largest grant, totaling $1.9 million, to train scientists and create lines of human embryonic stem cells.

“These grants will fuel the research of some of the most creative stem-cell scientists in the world, allowing them to pursue significant new directions in stem-cell research,” said Dr. Marc Lalande, professor and chairman of Ren-He Xu’s department. Lalande is associate dean for research planning and coordination at the University of Connecticut Health Center and director of the University of Connecticut’s Stem Cell Institute.

Lalande said the state-funded core lab is playing a critical role in the training of stem cell-scientists.

“This is a whole new way of thinking about human disease,” he said.

UCI scientist will visit Capitol Hill to share plans he has with other researchers regarding stem-cell treatments.

By Joseph Serna

Reporter JOSEPH SERNA may be reached at (714) 966-4619 or at joseph.serna@latimes.com.

Obama to Lift Restrictions on Embryonic Stem Cell Research

President Obama is expected to sign an executive order reversing a ban on federal funding of embryonic stem cell research, according to administration officials.

The officials said the president will announce the move at a Monday event at the White House, during which he will overturn a 2001 order by President George W. Bush that restricted federal funding of embryonic stem cell research to the existing 60 cell lines, according to reports by The Associated Press and CNN.

Obama's intent to lift restrictions on the controversial type of stem cell research has been known for some time! and is even articulated as part of his administration's agenda on The White House's Web site. But the exact date of when the reversal would take place was leaked on Friday.

Tony Perkins, president of the Family Research Council, accused the president of "leaking" the news on Friday so it would receive less attention.

He said the administration used the same tactic to announce the repeal of other pro-life orders, including the Mexico City Policy, which declared that American tax dollars would not fund international organizations involved in performing or promoting abortions abroad, and a Bush administration rule that federally funded health institutions comply with laws protecting the conscience of medical and health practitioners.

Perkins said the order would give a green light to the use of taxpayer funds for experiments that encourage human embryo destruction.

"I believe it is unethical to use human life, even young embryonic life, to advanc! e science," he said in a statement. "While such research is un! fortunat ely legal, taxpayers should not have to foot the bill for experiments that require the destruction of human life."

Embryonic stem cell research has drawn controversy because it necessitates the destruction of the embryo during the process of harvesting the stem cells.

Proponents of embryonic stem cell research point to the cell?s pluripotent ability ? or its capacity to become nearly all cell types and tissues in the body ? claiming that it holds the cure for debilitating diseases such as Alzheimer, Parkinson?s disease, and diabetes.

But pro-lifers, many of whom believe that life begins at conception, argue that destroying a human embryo is tantamount to killing human life. Many hold the view that embryonic stem cell research is not only unethical but also unsuccessful in producing cures or treatments for debilitating diseases.

Adult stem cell research is much more promising, pro-life advocates say.

"We should be increasing fundin! g for adult stem cell treatments, which have been used to treat patients for over 70 diseases and conditions, and we should fund the historic achievements in reprogramming ordinary skin cells into embryonic-like stem cells without compromising ethics by destroying life," stated Perkins.

Republican Congressman Chris Smith of New Jersey also echoed Perkins' sentiments.

"Why does the president persist in the dehumanizing of nascent human life when better alternatives exist? Human embryo-destroying stem cell research is not only unethical, unworkable and unreliable ? it is now, demonstrably unnecessary," said Smith, according to FOXNews.

In anticipation of Obama's decision, the National Institute of Health has started drafting guidelines, that among other ethical demands, are expected to require that the cells being used are derived with proper informed consent from the woman or couple who donated the original embryo, according to AP.

Dr. Arnold K! riegstein, director of the Eli and Edythe Broad Center of Rege! neration Medicine and Stem Cell Research at UC San Francisco, told the San Francisco Chronicle the NIH will probably not be permitted to fund the actual derivation of new embryonic stem cells, under a federal law limiting embryo research called the Dickey-Wicker amendment.

So. Illinois man seeks stem cell cure in China

By Carly O'Keefe

HOYLETON, IL (KFVS) - There's a lot of debate surrounding stem cell research, but a Washington County man says certain types of stem cell treatments do work and shouldn't be controversial.

The type that has everyone talking is embryonic stem cell research. Chuck Melton of Hoyleton suffered a debilitating spinal injury back in 2002, and has since undergone umbilical cord stem cell treatments in China using cells from umbilical cords donated to research after a baby is born. Melton says he's seen small improvements following his first treatment; for instance, his spinal injury limited his body's ability to sweat, but after the stem cell injections, that changed.

"Before I went, I couldn't even go outside the house if it was more than 85 degrees outside, because I would pass out from heat exhaustion," Melton said. "So that little bit of sweating has enabled me to go and enjoy my kids soccer games, baseball games and what have you, so that's a blessing right there."

Melton doesn't expect to walk after his second trip to China in May. He's just hoping for more signs of improvement, and maybe, just maybe--someday, a miracle.

"Ultimately I would love to one day stand and walk my daughters down the aisle, but I'm also trying to be realistic because that's a very long ways away," he said. "I don't expect going back to have the ability to walk, it might not happen, but if I continue to go back, 6-7 times and continue to show small improvements, that'll be great, and hopefully I can pursue treatments someday here in the states."

Melton's friends and family are selling raffle tickets for $20 a piece to help pay for his next round of treatments in Qingdow, China coming up in May. They're raffling off a Bad Boy buggy, a 42-inch hi-def TV, a Touring 150 Deluxe Scooter, and a Dell laptop. If you would like to purchase a raffle ticket or donate to Melton's effort, contact Chuck Melton at 618-493-9001. For more information about Chuck Melton's stem cell treatments, log onto www.stemcellschina.com.

Senate OKs stem-cell bill

SANTA FE — A bill allowing human embryonic stem cell research in New Mexico was approved Thursday by the Senate.

Supporters say the research may lead to cures and treatments for illnesses such as Parkinson's disease and to repair damaged tissues, such as in spinal cord injuries. Stem cells are the building blocks for other cells in the body.

Under the bill, couples with leftover embryos at in-vitro fertilization clinics could donate them for research rather than have them discarded by the clinics.

"I just want to give these couples another option other than destroying them," said Sen. John Ryan, R-Albuquerque, who sponsored the legislation.

He said his late mother-in-law had suffered from Alzheimer's.

"It's one of the worst diseases we have," he said. "What it does to the family is one of the hardest things a family will have to go through."

Ryan estimated that 1,000 embryos are discarded by fertility clinics each year in New Mexico.

Opponents voiced objections to using human embryos for research.

"Open your hearts and minds to the possibility that a human is a human from the beginning," said Sen. William Sharer, R-Farmington.

He said he understood the desire of supporters to find cures for diseases, pointing out that his wife had received a pancreas transplant and was no longer diabetic. However, he said there were other types of stem cells that could be used by scientists.

Supporters said the bill did not raise the same ethical and moral questions that dominate the public debate about abortion.

"This is not a bill that creates life to destroy it. The life is already there. The embryos are already there," said Sen. Rod Adair, R-Roswell.

Adair supported the bill, saying, "Are we going to continue to wantonly waste 1,000 embryos a year for no reason or will some possible good come out of it. That's the only choice."

Sen. Mary Jane Garcia, D-Dona Ana, said she had a sister who suffered from Alzheimer's.

"I think it's a bill that's about life. It will give life to other people," she said.

The bill cleared the Senate on a 27-14 vote and was sent to the House, where similar proposals have failed the past two years.

Gov. Bill Richardson supports the stem cell research proposal. He praised the Senate for "recognizing that our clinical research laws are out of date and for passing this important legislation that could lead to potentially life-saving research under careful conditions and important restrictions."

President Barack Obama is expected to soon lift a ban on federal funding for embryonic stem cell research. Under President George W. Bush, federal money for the research was limited to embryonic stem cell lines created before Aug. 9, 2001.

The stem cell research bill is SB77.

Scientists Heartened at Prospect of End to Stem Cell Ban

By Amanda Gardner
HealthDay Reporter

MONDAY, Feb. 9 (HealthDay News) -- Researchers are rejoicing over President Barack Obama's anticipated lifting of the eight-year ban on embryonic stem cell research imposed by his predecessor, President George W. Bush.

The anticipation moved one step closer to reality Thursday, with media reports that Obama gave House Democrats at a closed-door Virginia retreat a "guarantee" that he would sign an executive order overturning Bush's policy.

"It's going to remove an embarrassment for American science," said Dr. Darwin Prockop, director of the Texas A&M Health Science Center College of Medicine Institute for Regenerative Medicine at Scott & White Hospital in Temple. "It's a statement that we're going to again believe in science."

Yet those same experts are aware that the sobering state of the economy could impose its own restrictions on this type of research.

"This clearly is a very important part of our medical future," said Paul Sanberg, distinguished professor of neurosurgery and director of the University of South Florida Center of Excellence for Aging and Brain Repair in Tampa. "[But] to clear the path for this without giving additional money to the National Institutes of Health will be disappointing. I hope the stimulus package also includes an increase in embryonic stem cell funding."

Sanberg also expressed concern that any monies redirected to stem cell research could divert funds from other critical avenues of research. "If it's a normal competitive process, it will take money away from other programs," he said.

Stem cell research received a big boost in January, when the U.S. Food and Drug Administration approved the first-ever human trial using embryonic stem cells as a medical treatment.

Geron Corp., a California-based biotech company, was given the OK to implant embryonic stem cells in eight to 10 paraplegic patients who can use their arms but can't walk.

In 2001, then-president Bush limited federal funding for stem cell research only to human embryonic stem cell lines that already existed.

The decision prompted some scientists to worry that the United States would fall behind other countries in the drive to unlock the potential of stem cell research.

Embryonic stem cells are the most basic human cells, believed to be capable of growing into any type of cell in the body. Working as a sort of repair system for the body, they can theoretically divide without limit to replenish other cells. The scientific hope is that stem cells may, at some point in the future, become capable of treating a variety of diseases and conditions, such as Parkinson's disease, diabetes, heart disease and spinal cord injuries, according to the U.S. National Institutes of Health.

National polls continue to find that the majority of Americans favors embryonic stem cell research, although some surveys have found that that support has declined somewhat in recent years.

Many people object to the use of embryonic stem cells, contending that the research requires the destruction of potential life, because the cells must be extracted from human embryos.

The stem cells being used in the recently approved Geron trial were obtained from one of the Bush administration's approved stem cell lines. And no federal funds were used in the development of this treatment.

Since the restrictions on embryonic stem cell research took effect, many research institutions have redirected their focus to other types of stem cells. Prockop's institution, for instance, deals only with adult stem cells.

Adult stem cells can give rise to all the specialized types of cells found in tissue from which they originated, such as skin. But, scientists don't agree on whether adult stem cells may yield cell types other than those of the tissue from which they originate, according to the National Institutes of Health.

Prockop said embryonic stem cells "are mainly of interest as a research tool and a biological experimental system. Their use in patients in spite of that recent approval for Geron is really very questionable because of the potential for tumors."

Still, the anticipated lessening of restrictions by the Obama administration may help funnel more private money into stem cell research, the experts said.

"This should give more general acceptance to stem cell research, because now, there won't be this stigma associated with it as much," Sanberg said.

And, perhaps, a new federal policy would spur organizations such as the American Heart Association -- which currently does not fund research involving human embryonic stem cells or stem cells derived from fetal tissue -- to channel funds into this line of research, Sanberg added. (The heart association said it "recognizes the value of all types of stem cell research and supports federal funding of this research.")

Still, Sanberg pointed out, some ethical issues surrounding stem cell research and its application will remain.

For instance, he said, "There still needs to be some oversight on the uses of stem cells and cloning."

To learn more about stem cells, visit the U.S. National Institutes of Health.

Human stem cell study gets approved

"Politics played no role in the FDA's decision. These things are a process. The timing was governed by the waiting for the company to come back to us with an answer to one of our previous questions. It's about science, not politics."-Karen Riley, FDA pres

By: Tamara Howard, Daily Vidette Staff Writer

The Food and Drug Administration has recently approved the first human trials of human embryonic stem-cell research, to be performed by Geron Corporation.

The researchers will test whether the cells are safe to use in spinal injury patients.

Embryonic stem cells are blank cells found in four- to five- day old embryos that have the ability to turn into any cell in the body.

Many objections come from the fact that when the stem cells are removed, the embryo is destroyed. Still, there are other reasons.

"[Geron] Corporation is all about making money, not about helping everyone, just those who can pay," Cecilia Castro, a Heartland Community College sophomore, said.

"They also don't know if it will cure or hurt someone in the end."

According to a CNN article, these patients have to have complete spinal cord injuries that have occurred within seven to 14 days.

The tests will use stem cells cultured from embryos left over in fertility clinics, which otherwise would have been discarded.

The primary purpose of the trial will be to see if the patients will be safe during the injection of the cells. The patients will be monitored for a year after the injections to see if they are regaining some kind of function below the injured point.

The trials will include eight to 10 patients who are completely paralyzed below the third and tenth vertebrae.

As reported by CNN, researchers and advocates have complained that the former restrictions set back work toward curing diseases such as Alzheimer's, Parkinson's and diabetes.

However, that was not the underlying decision in the FDA's approval.

"Politics played no role in the FDA's decision," Karen Riley, FDA press officer said. "These things are a process."

"The timing was governed by the waiting for the company to come back to us with an answer to one of our previous questions. It's about science, not politics."

Researchers are expecting President Obama to undo George W. Bush's former policies regarding the subject.

Jamie Thomson of the University of Wisconsin-Madison developed the first human embryonic stem cells in 1998.

However, federal research funds were prohibited for embryonic stem cell research until 2001.

At the time, former president George W. Bush approved spending for research using only already existing cell lines. It was later discovered that those kinds of lines were rarely useful for research.

The trials are expected to start in the summer due to needed FDA approval.