On Friday, it was announced that an agreement has been reached between Geron and the FDA.  Early-stage study for Geron’s stem cell drug therapy on people recently suffering complete thoracic spinal cord injuries, is tentatively expected to restart in the third quarter of 2010.

Last August, the trial was placed on hold after studies showed that some mice had developed cysts at the injury site in previous studies.

The US food and Drug Administration has advised Geron that positive data from an ongoing preclinical study using Geron’s stem cell therapy, may be used to release the current hold on the study.  A lot of work is ahead though for Geron.

If and when the clinical hold is released for Geron, there will be many hurdles to cross.  I expect it may be awhile before the study’s move from the thoracic level to cervical level injuries.

It will be interesting to hear what Geron has to say about these trials at their next quarterly report.

Well this is horrible news.

“Aug 27 (Reuters) – Stem cell research company Geron Corp (GERN) said animals injected with its experimental cell therapy for subacute spinal cord injury developed microscopic cysts in the injury site.  However, a manufactured lot of the drug GRNOPC1 that was assessed using new markers and assays showed no cysts in a recently concluded study in rats, the company said in a statement.”

Geron’s IND application, and the trial, was placed on hold last week, as this data was presented to the FDA for further discussion.

I’m not a medical doctor, researcher, or part of the FDA, but I will be surprised if this stem cell trial is allowed to continue.  I was really hoping this trial would show some promising results, but it looks as if it will end before it even gets started.

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