DAVID GRANOVSKY

Geron’s Stem Cell Trial

In BUSINESS OF STEM CELLS on November 3, 2009 at 11:07 am

[For more articles on the long, sordid and somewhat pathetic history of Geron’s embryonic stem cell clinical trial to treat spinal cord injury, click here]

Spinal Cord Injury

Geron Corporation’s Stem Cell Trial

Monday November 2, 2009

Geron Corporation is a company based in Menlo Park, CA and the first biotech company in the USA to be granted permission for a clinical trial of regenerative medicine using embryonic stem cells, in humans. While permission was granted in January 2009, the trials were put on hold until last Friday (October 30, 2009) when the latest round of preclinical trials using animals revealed some side effects that warranted further investigation.

According to the Geron News Release, test animals receiving the treatment, GRNOPC1, developed a higher number of cysts at the area of spinal cord injury than in previous studies. However, the FDA has agreed to allow the studies to continue, since the cysts appear to be non-proliferative, confined to the injury site, and not associated with any serious adverse effects or SUSARS.

GRNOPC1 consists of human embryonic stem cell (hESC)-derived oligodendrocyte progenitor cells (OPCs). Oligodendrocytes are cells of the nervous system that produce the myelin shealth, which insultates the axons of nerve cells. Injection with the cells was shown to enhance remyelination of the spinal cord in adult rats. Demyelination after spinal cord injury contributes to loss of neural function. Rats treated with GRNOPC1 seven days after injury exhibited substantially better recovery and improved locomotor ability.

Geron expects re-initiation of the clinical trial in late 2010. Since the treatment must be applied shortly after injury, anyone wanting to participate in a clinical trial must agree to injections within 7 to 14 days of spinal injury…

via Geron Corporation’s Stem Cell Trial.

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