Geron Trials Delayed

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Have you been following the clinical trials from Geron Corp?

Geron is the first biotechnology company to be FDA approved to test stem cells on humans for the treatment of spinal cord injuries. These trials had been delayed since May 08 but the ban was lifted by the FDA in Jan 09.

There is speculation but no proof that the delay may have had a political motive since the previous administration opposed work performed using embryonic stem cells while the current administration, which coincidentally also began in Jan 09, has been a supporter of this avenue of research.

That being said, Geron had identified several institutions in which to begin the trials but before anyone could be enrolled, the trials were postponed by the FDA on August 18th.

Typically, Phase I trials are dose related and used to establish the safety of the protocols used rather than to establish treatment effectiveness. Since Geron recently submitted additional higher-dose data, there is speculation that there may be concerns at the FDA related to these new findings.

This does not mean the end of the trials but, instead, Geron will work with the FDA to review the new data with the hope of lifting the delay in the near future.

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