FDA: Stem Cell Trial Can Proceed

WASHINGTON, July 30 (UPI) — The Food and Drug Administration has given approval to proceed with the world’s first human clinical trial of a human embryonic stem cell-based therapy.

Geron Corp., headquartered in Menlo Park, Calif., says it will proceed with its trial of GRNOPC1, a stem-cell therapy intended to treat patients with acute spinal cord injury, a company release said Friday.

“We are pleased with the FDA’s decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed,” Geron President and Chief Executive Officer Thomas B. Okarma said. “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 … progenitor (stem) cells directly into the lesion site of the patient’s injured spinal cord.”

“The neurosurgical community is ready to begin the clinical testing of this new approach to treating devastating spinal cord injury,” said Richard Fessler, professor of neurological surgery at the Feinberg School of Medicine at Northwestern University. “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.”

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