The Geron Corporation, Menlo Park, Calif, is beginning phase one of a clinical trial for a human embryonic stem cell-based therapy, [removed]GRNOPC1[/removed], in patients with spinal cord injury. Data on the first two patients were presented at the 2011 International Conference on Spinal Cord Medicine and Rehabilitation, Washington, DC.
A second presentation was given at the 2011 Spine Symposium, which was held as part of The American Spinal Injury Association (ASIA) Annual Scientific Meeting. The presentations were given by Edward Wirth, III, MD, PhD, Geron’s medical director for cell therapies, and Linda Jones, PT, MS, Geron’s senior clinical trials manager for GRNOPC1.
"We are pleased to report a very good safety profile of GRNOPC1 to date, with no serious adverse events," said Wirth. "Currently, we have two patients in the trial. We anticipate increased enrollment going forward as we open our additional clinical sites and following FDA approval to expand our inclusion criteria to patients with injuries resulting in a neurological level of T11, which represents a substantial percentage of thoracic injuries, and to reduce the stagger between patients from 30 days to 10 days."
Data were presented on two patients with neurologically complete ASIA Impairment Scale grade A thoracic spinal cord injuries, who received GRNOPC1 at a dose of 2 million cells delivered by injection into the lesion site using a syringe positioning device specially designed by Geron. GRNOPC1 was administered between 7 and 14 days after injury. Low-dose tacrolimus was given for temporary immune-suppression from the time of injection for 46 days, at which point the dose was tapered and withdrawn completely at 60 days.
[Source: Geron Corp via Medical News Today]
