Embryonic stem-cell trial put on hold

[Ilsa]

I don't think they want to learn more about the ES risks, so they are claiming ignorance, but it is based on their policy of rejecting ES.

Embryonic stem-cell trial put on hold

Future clinical test still waiting for the go-ahead.

Monya Baker

The first potential clinical trial of a cell therapy derived from embryonic stem (ES) cells has been put on hold by the US Food and Drug Administration (FDA). Researchers say this reflects the still-unknown risks of such treatments in humans.

Biotech company Geron in Menlo Park, California, has been talking to the FDA for more than four years over its proposal to inject patients who have spinal cord injuries with oligodendroglial progenitor cells grown from ES cells. The company announced last week that it had received a “clinical hold” on its application, but that the FDA has not yet disclosed the reasons why.

Researchers are unsure whether the agency’s action reflects specific problems with Geron’s trial or more general concerns about the safety of all ES-cell-derived therapies, in which case other pending trials might also be delayed. To enter trials, companies will need to provide convincing data that the transplanted cells are safe, and particularly that no undesirable cells will cause tumours or other harm, says Ole Isacson, a neuroscientist at Harvard Medical School.

snip

Awaiting approval
The hold comes a month after the FDA held its first advisory meeting on how best to evaluate products derived from ES cells. Industry analyst Steven Brozak of WBB Securities in San Diego, California, worries that the decision for the hold was motivated by political objections to ES-cell research, but researchers in the field discount this, saying that the agency is genuinely uncertain about how to ensure safety.

snip

[blondeatlast]

1. Let's see, how many dangerouis drugs have been pushed through with little or no independent testing?

But the postponement of ES testing isn't at all political, nosirree, not in the least, don't you believe it... :eyes:

These sphincters are as transparent as air.

[Ilsa]

2. Thanks for reminding me of how they've dropped the ball

over the last few years when it comes to Vioxx, etc. You are dead on: it is to assuage the religious rightwingers.

I'm going to keep this kicked so people will see that it DOES make a difference who we put in the WH.

[blondeatlast]

3. Kick for a sadly neglected issue. nt

[Ilsa]

4. More need to know about this. It seems like a tiny issue on the

big stage of the election, but I wonder how many other ES research trials are being held up by the Magisterium of FDA or the companies because they know trials will be rejected. How many people could be helped by this? Other people with Alzheimers or Parkinsons?