Stem Cell Blockbuster During Obama's First Week

Michelle Schlief of ABC News' Medical Unit:

Word of the FDA approval of Geron’s clinical trial to treat recent spinal cord injury patients with human embryonic derived cells has drawn enthusiasm from leading stem cell researchers. And there are already indications that other applications will be soon to follow. Dr. Robert Lanza of Advanced Cell Technology tells us that his company plans to file with the FDA to begin a clinical trial this summer testing a prevention for blindness using embryonic stem cells. One of the leading experts in the use of stem cells for spinal cord injury repair, Dr. Naomi Kleitman of the National Institutes of Health, says one of the biggest holdups with using embryonic stem cells has been that the cells haven’t been able survive in a patient – but the fact that this trial is happening is proof that Geron has found a solution to this problem. Dr. Nicholas Ahn, assistant professor of orthopedic surgery at University Hospitals in Cleveland, believes that the choice to begin the trial in spinal cord injury patients is particularly good because of the lack of treatment options – “there is so much potential,” he said. “A door has been closed for a long time and it has finally opened.” Dr. Kleitman believes that going forward we’ll be seeing more funding and encouragement for stem cell research from the Obama Administration. While many have dismissed the idea that the timing of the FDA’s decision has anything to do with the change of power in Washington, others, like Dr. Lanza, speculate that the FDA might feel freer to push forward knowing that one of President Obama’s campaign promises was to reverse former President Bush’s ban on funding for embryonic stem-cell research. There is an expectation in the air that President Obama will issue an executive order reversing this ban sometime next week. However, one source believes it is possible that the President may turn the issue over to the National Institutes of Health for their recommendation, in order to defer the controversial issue. Going forward, ethicist Ruth Faden executive director of the Johns Hopkins Berman Institute of Bioethics, cautions that the FDA must be vigilant in watching this trial, since this is the first time embryonic derived stem cells will be given to humans. "If the trial goes well than this would be a boost for [this area] of science which could also increase support from the public," she said. In the trial, a group of approximately 10 paraplegics who have recently lost the use of their legs will be injected with cells derived from embryonic stem cells, according to Dr. Tom Okarma, president and CEO of Geron Corp., who spoke with Good Morning America earlier today. These stem cells have been pushed in a direction that will help the damaged spinal cord, said Dr. Kleitman. These cells play a supporting role and help the nerves to start working properly again, she said. “If Geron can show it’s safe to derive stem cells into patients, that will be an important precedence to enhance future trials for all diseases that could benefit from this work – from juvenile diabetes to other types of neurological disorders,” said Dr. Sean Morrison, Director of the University of Michigan’s Center for Stem Cell Biology, in an interview with “GMA.”

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