FDA Delays Application For First Human Trial Of Embryonic Stem Cells

Main Category: Stem Cell Research
Also Included In: Women's Health / Gynecology;  Regulatory Affairs / Drug Approvals
Article Date: 19 May 2008 - 7:00 PDT

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The company Geron on Wednesday announced that it has received oral notice from FDA that the agency is delaying a decision on the company's application for the first clinical trial using human embryonic stem cells in humans, Bloomberg/New York Times reports. Geron CEO Thomas Okrama said the company is waiting for a written explanation from FDA as to why it is delaying a planned trial to test a stem cell compound in patients with spinal cord injuries. He said the company will announce details of the clinical trial once it receives the letter from FDA. "We are disappointed with this action given the interactions we had with the FDA over four years leading to the filing" of the 21,000-page application for the trial, Okrama said (Bloomberg/New York Times, 5/15).

An FDA advisory panel last month examined how the agency will regulate human clinical trials using treatments derived from embryonic stem cells. During the meeting, Steven Bauer, chief of FDA's cell and tissue therapy branch, said that because of the potential risks involved in embryonic stem cells and data on the effectiveness of treatments using them "may need to be particularly strong" (Daily Women's Health Policy Report, 4/14).

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