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A clinical trial that would test the use of embryonic stem cells to treat spinal cord injury could begin within three months.

The Scientist is reporting that the Food and Drug Administration (FDA) may lift its hold on a trial sponsored by California biotech Geron Corp. by early next year. In May, the agency ordered Geron to delay the trial while it studied how best to regulate stem-cell-based therapies.

The phase 1 trial would test whether it is safe to inject nerve cells into the site of a spinal cord injury. A study published in 2005 in the Journal of Neuroscience found that giving rats the injections seven days after a spinal cord injury improved their motor function.

Geron president and CEO Tom Okarma said there's no indication that politics were behind the FDA's delayed approval, according to The Scientist. He made his remarks at the New York Stem Cell Foundation conference at Rockefeller University last Wednesday.

President Bush banned federally funded research on embryonic stem cell lines created after Aug. 9, 2001. Democratic Presidential nominee Barack Obama told the group Science Debate 2008 that he would lift the limit, but John McCain, who has said he supports such research, has not made clear whether he would do so.

Among the concerns about stem cell therapy is whether it might cause cancer.

An FDA spokeswoman said the agency doesn't comment on products under development.

(Updated at 8:10 a.m. Tuesday with FDA response.)

(Image by iStockphoto/Mads Abildgaard)

4 Comments

1. 1. freddyboy 08:29 PM 10/23/08

   This article doesn't seem to offer any strong evidence in support of a lift of the hold. Only that a new administration will increase funding. However the CEO of Geron has said that the hold wasn't political. We knew all this already! where is the news? Has the FDA finally written a letter explaining the hold? not as far as I can tell - at least Geron hasn't released it yet. It is very frustrating to finally find a new article relating to this ridiculous hold and then find that its one interesting claim (where did this "3 months" figure come from?) is void of complimentary evidence.

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2. 2. Mirella Cueva 08:48 PM 1/6/09

   Casey Nabavi and Cellulogix Biosciences recently opened their headquarters in Montreal, Canada. With treatment centers in Zona Rio, Mexico and Istanbul, Turkey. Coming soon are treatment centers in Germany and Russia, as well as Cabo San Lucas.
   
   www.cellulogixintl.com

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3. 3. Outdischair 11:15 PM 5/21/09

   Plz plz give me a call or email me about your injection been in a wheelchair to long got feeling but can move my legs will do whatever it take anyone somebody plz contact me at wallace601@bellsouth.net GoD is watching and he sent me here so plz contact.

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4. 4. kaushikshahukar 06:17 AM 6/3/10

   Does Stem Cell is useful in Curing Secondary Dystonia how superior is to brain stinulation Surgery.
   
   Regards
   
   kaushik Shahukar
   (9892942721)

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