Geron's embryonic stem cell trial gets go ahead
The FDA has given permission for Geron to try an embryonic stem cell based therapy for spinal cord injury in up to 10 patients. The approval was granted on Wednesday, just a day after Barack Obama's inauguration as president, but both FDA and Geron say the timing is coincidental, according to an article in the Wall Street Journal.
Here is a press release from the company.
In spring last year, the FDA refused to let the trial go ahead. Analysts and advocates I spoke to were convinced this was because of political reasons, but that opinion was not shared by the half-dozen or so scientists I spoke with (some of whom credibly claimed inside knowledge of the proceedings). Though embryonic stem cells have potential to become any sort of cell in the body, regulators, scientists, and others worry that the cells are unpredictable. Since spinal cord injury is not a fatal disease, regulators fear that an experimental therapy that goes wrong could shorten someone's life. At the FDA hearing I attended in April last year, patient advocates pled with regulatory officials to consider quality and not just length of life when weighing the potential risks and benefits of a new treatment.
Here are some related articles:
Weiging risks and rewards on the way to the clinic
What stem cell therapy can learn from gene therapy
FDA places Geron's clinical-trial on hold (free blog from May 2008)
Embryonic stem-cell trial placed on hold (subscription news from May 2008)
FDA to vet embryonic stem cells' safety (subscription news, preview of the meeting)
FDA questions on making safe products from embryonic stem cells
