Geron gets FDA approval for spinal cord injury clinical trialRSS Feed

02 August 2010

Spinal cord injury patients could be one step closer to seeing stem cell-based treatments being used in humans, after a leading biotech company got the go-ahead to proceed with clinical trials.

California-based firm Geron has been given the all clear to conduct human clinical trials of stem cell therapy on patients with acute spinal injuries by the US Food and Drug Administration (FDA).

It is hoped that the product, GRNOPC1, will repair some of the spinal cord tissue in spinal injury patients and restore some degree of movement to those who are paralysed.

The FDA had put the programme on hold after safety concerns were raised over some of the outcomes recorded in trials on rats, but it seems that it is now satisfied with the treatment.

Richard Fessler, professor of neurological surgery at the Feinberg School of Medicine at Northwestern University, commented: "If found to be safe and effective, the therapy would provide a viable treatment option for thousands of patients who suffer severe spinal cord injuries each year."

US firm Geron, which also owns a subsidiary operation in Edinburgh, specialises in biopharmaceuticals for the treatment of cancer, spinal cord injuries, heart failure and diabetes.

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Posted by Matthew Heap ADNFCR-2547-ID-19916385-ADNFCR