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.
Dear Reader,
Can I be direct with you?
War abroad. Socialists on the rise. AI upending human life. Endless uproar online. The modern attention economy doesn’t want readers — it wants users enslaved to the tyranny of the present.
First Things is the antidote: literary excellence, timeless truths, and a fixed point of reference in a culture that has lost its bearings.
But we can’t do it without readers like you.
Our goal: Raise $150,000 by November 1 to sustain First Things in the year ahead.
Your gift anchors readers in the permanent things.
Make your Fall Campaign gift now using the button below.
If you have any questions or would like more information, please contact Giovanni Del Piero, Director of the Editor’s Circle, at gdelpiero@firstthings.com or 212-627-1985.
YOU MIGHT ALSO LIKE
The Church in the Age of Therapy
In 1966, Philip Rieff wrote in The Triumph of the Therapeutic that “Religious man was born to…
Canada’s Deadliest Blind Spot
On September 20, the Daily Mail ran a story with the provocative headline, “Our 83-year-old Christian grandmother…
The Faithful Joy of Dolly Parton and Fulton Sheen
Dolly Parton and Fulton Sheen seem to have had little in common. She favored rhinestones; he wore…
