At yesterday's hearing on stem cells, the FDA set a high bar for the treatments, saying that any therapies would have to have very compelling data in order to move into human trials. The FDA's wariness is due to uncertainty about stem cells effects on the body. While the treatments show promise, researchers do not yet have all the answers regarding the long-term effects of such treatments. Tumors, in particular, are a concern. Geron, Novocell, Neuralstem and Advanced Cell Technology are nearing human trials--uncharted territory for stem cell therapies.
The FDA took a key step as it began drafting a blueprint for how the stem cell therapy trials would be conducted. "We've talked about how long we need to monitor people for, and the answer is forever," said Gordon Weir, a panelist on the advisory committee. "We're putting in these cells, and we don't know what they're going to cause in terms of trouble."Â Drug developers are looking to the FDA to elucidate the regulatory hurdles they'll face as stem cell therapies move through clinical trials. Without clear guidelines, drugmakers will face an unclear development process complicated by uncertainty and controversy.
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