Human Exceptionalism

No Human ESCR Trials per FDA

Geron Corporation has released a series of press releases over several years stating that “next year” it would start the first human trials using ES cells. Apparently, that won’t be happening yet. From the story:

The F.D.A. convened a meeting April 10 of expert advisers who stressed the need for stringent safety measures in embryonic stem cell trials.

Steven Bauer, chief of the F.D.A.’s cell and tissue therapy branch, said at the meeting that the agency might require “particularly strong” evidence early in studies that stem cell treatments are effective. The agency may also require longer trials of stem cell therapies than it does for conventional drugs, Mercedes Serabian, a supervisory toxicologist for the agency, said after the meeting.

The company will announce its plans once it receives the F.D.A. letter, Mr. Okarma said. “We are disappointed with this action given the interactions we had with the F.D.A. over four years leading to the filing” of the company’s 21,000-page application for the trial, he said.

Tumors are an important worry, as is efficacy. Meanwhile, those adult stem cell advances keep rolling in.