The Geron Corporation could be cleared to resume its stalled human embryonic stem cell (hESC)-trial for spinal cord injury in the third quarter of next year, the company announced today (October 30).
Nissim Benvenisty "The Scientist.com"
The Phase I trial, which received clearance from the US Food and Drug Administration (FDA) in January to administer hESC-derived progenitors of neural support tissue into the spinal cords of patients with severe spinal cord injury, is the first-ever clinical trial of a hESC-based therapy. In August, however, before any patients could receive treatment, the FDA put the trial on hold after cysts appeared in some of the animals that had been given the treatment as part of a preclinical study.
Since then, Geron has continued its preclinical study of the treatment, using new markers and assays agreed upon with the FDA, according to their press release. If the study continues to show positive results, the FDA has agreed that the trial could restart in the third quarter of next year.
Still, "a great amount of work still needs to be done before any patient is ultimately enrolled into the study," Merriman Curhan Ford analyst Joe Pantginis told Reuters.
Nissim Benvenisty "The Scientist.com"
The Phase I trial, which received clearance from the US Food and Drug Administration (FDA) in January to administer hESC-derived progenitors of neural support tissue into the spinal cords of patients with severe spinal cord injury, is the first-ever clinical trial of a hESC-based therapy. In August, however, before any patients could receive treatment, the FDA put the trial on hold after cysts appeared in some of the animals that had been given the treatment as part of a preclinical study.
Since then, Geron has continued its preclinical study of the treatment, using new markers and assays agreed upon with the FDA, according to their press release. If the study continues to show positive results, the FDA has agreed that the trial could restart in the third quarter of next year.
Still, "a great amount of work still needs to be done before any patient is ultimately enrolled into the study," Merriman Curhan Ford analyst Joe Pantginis told Reuters.