Yes!  Geron has received the green light from the FDA to begin the Phase I clinical trials of GRNOPC1 in people with acute (this means people newly injured, and probably in ICU) spinal cord injuries.

This signifies the first time a human embryonic stem cell (hESC)-based therapy will be used on humans (in the United States).  Currently other countries such as China and European nations are proceeding with embryonic stem cell therapies, but the documentation on the procedures used and success rates are sketchy.

With FDA approval to proceed in the United States, it will mean that Geron will follow strict guidelines every step of the way.  In Phase 1, patients with “complete” injuries will receive the GRNOPC1 therapy.  Paraplegics with injuries from the T3 to T10 spinal column will be injected (with their consent) between seven and 14 days after injury to the spinal cord.

“We are pleased with the FDA’s decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed,” said Thomas B. Okarma, Ph.D., M.D., Geron’s president and CEO. “Our goals for the application of GRNOPC1 in subacute spinal cord injury are unchanged — to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient’s injured spinal cord. Additionally, we are now formally exploring the utility of GRNOPC1 in other degenerative CNS disorders including Alzheimer’s, multiple sclerosis and Canavan disease.”

Safety of the therapy will be assessed as well as the awaited results of improved changes in movement and sensation in the lower extremities and legs.

With the success of this first phase, Geron will extend the study. Newly injured patients with complete cervical injuries, and then patients with severe incomplete (ASIA Impairment Scale grade B or C) injuries, will undergo the therapy.  Each phase must meet FDA approval.

U.S. Medical test sites (up to seven) conducting the therapy, will be announced as patients (unlucky but possibly very lucky)  are enrolled in the study.

Good luck Geron!

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.