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California Company Gets FDA Approval for Embryonic Stem Cell Clinical Trials for Spinal Cord Injury Therapy

Wednesday, August 04, 2010

A California-based company has received the go-ahead from the Food and Drug Administration for embryonic stem cell clinical trials to treat spinal cord injury and other conditions.  The company, Menlo Park-based Geron Corporation, has announced in a press release that the FDA has lifted its hold on the company's clinical trials.  The agency has given its approval for the Phase 1 clinical trial of GRNOPC1, in patients who suffer from severe spinal cord injury, to proceed.  This is the world's first clinical trial of human embryonic stem cell-based therapy for treatment of spinal cord injury.

The therapy centers on injecting embryonic stem cells into the spines of those suffering from the injury.  Researchers and California spinal cord injury lawyers hope that the embryonic stem cells will trigger the growth of damaged nerve cells, and will ultimately lead to the patient regaining movement and sensation in the affected area.  The study had been placed on hold by the FDA last year after some of the animals in the study developed cysts.  President Obama had given the go-ahead for the embryonic stem cell clinical trials last year, but Geron had been waiting for the FDA to lift its hold on the clinical trial. 

If the clinical trials are successful, it would mean a revolutionary development for the thousands of spinal cord injury patients not just in the US, but across the world.  In the US alone, there are approximately 2 million people living with some degree of spinal cord injury.  These people would have new hope if the clinical trials are successful. 

Much of that hope comes from the fact that embryonic stem cells are very versatile, and have the ability to turn into any kind of cells.  Researchers are hoping that this quality of embryonic stem cells will lead to the generation of new cells in the spine area, thereby helping the patient regain movement.  It's not just patients with spinal cord injury who might benefit if the clinical trials are successful.  Patients with Alzheimer's disease and multiple sclerosis could also benefit from the therapy.

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