Monday, January 26, 2009

FDA approves first clinical trial using cells derived from embryonic stem cells

Lots of events transpired while I was in Washington, D.C. including the FDA’s decision to approve Geron’s clinical trial to test the safety of cells created from embryonic stem cells in patients with spinal cord injuries. According to the Reuters article, the first treatment will start sometime in the summer.

Like Rebecca Taylor, I’m concerned about the safety of these patients. I’ve read way too many of Thomas Okarma deceptions to trust the safety of Geron’s products.

This part (from the LA Times article linked above) is also very interesting:
The cell therapy is made from one of the first batches of human embryonic stem cells ever created. Researchers had feared those cells could never be used to treat people because they were derived using molecules from mice and cows and thus might be rejected by the human immune system. Newer stem cell lines that are animal-free have not been eligible for federal research funding under the policy set by President Bush in 2001. As a result, many people had expected FDA approval for any embryonic stem cell therapy to be years away.

Now, however, the FDA appears satisfied that the stem cells are safe for human use, and more clinical trials are sure to follow, said Amy Comstock Rick, president of the Coalition for the Advancement of Medical Research, a patient advocacy group that supports stem cell research. "It shows that things are starting to move through the pipeline," she said.

How many times were we told that Bush’s stem cell policy needed to be reversed because the old embryonic cell lines were grown on mouse feeder cells? How many times were we told the U.S. was falling behind other nations because of Bush’s funding restrictions? Now the FDA has approved the first clinical trial in the world with cells derived from embryonic stem cell created by private funding on one of the very early cell lines.

Also note the timing of when the injuries have to take place.
The first patients to get the treatment will be injected with 2 million of the cells seven to 14 days after a spinal cord injury. If they are administered sooner, the cells could be damaged by inflammation from the injury. If doctors wait too long, there might be too much scar tissue for the cells to find room to grow, Okarma said.
So people paralyzed for years aren’t going to be magically stand up and walk? Someone tell John Edwards.

From the AP article, it seems like cost could also be an issue.
Okarma said he can't estimate how much such a therapy would cost if it proves effective, but that "this is not going to be a $500,000 price tag. It will be remarkably affordable ... in the context of the value it provides."
So it won’t be $500,000, it will just be $400,000 per patient if it actually works.

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