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The Food and Drug Administration (FDA) has just tapped a Northern Californian biotech company to perform the first human clinical trial using embryonic stem cells. Geron, the company, applied for FDA’s approval last March. This will be a phase-one study looking at safety measures, but researchers said they will wait and see whether the therapy is working.
Researchers want to inject stem cells into the spines of the patients who have recently suffered a devastating spinal cord injury and seven medical centers have already been selected to participate in the trial, but the hospitals must have the study approved by their internal review boards.
As for the hypothesis that the change in administration led to the approval of Geron’s study, company officials denied it. They hope the therapy will be able to restore movement, perhaps organ function or just sensory function for the person at the site of the injury. The stem cell line in the study is one of the oldest, so it was eligible for funding under the Bush Administration’s policy.
However, many experts fear embryonic cells injected into patients could grow into tumors, and that is a major concern to the US Food and Drug Administration. For now, the treatment was successful on rats, which regained the ability to walk and run, an ability they once lost.
Another use for the stem cells could help patients with Type 1 diabetes, as they can turn into insulin-secreting islet cells. In addition, they can also turn into cardiac tissue that could repair damage made by heart attacks. As for the spinal cord therapy, it looks like the stem cells won’t help paralyzed patients walk again, but it could substantially improve their quality of life.
However, researchers say that a cure could still be years away, and it remains to be seen if there will be any success with this kind of treatment.
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