FDA Clears Geron to Start World’s First Trial with hESC Therapy
Geron will be able to start what it claims is the world’s first human trial with a human embryonic stem cell (hESC)-based therapy now that FDA has lifted a nearly year-long clinical hold on the firm’s IND application for its acute spinal cord injury therapy, GRN
Looking forward, Geron says once the safety of GRNOPC1 has been confirmed in this first patient population it will look to increase the treatment dose, enroll additional subjects with complete cervical injuries, and expand the trial to include patients with severe incomplete injuries classified as
“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 hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient’s injured spinal cord,” states Thomas B. Okarma, M.D., Geron’s president and CEO. “Additionally, we are now formally exploring the utility of GRN
GRNOPC1 comprises hESC-derived oligodendrocyte progenitor cells that published studies have shown demonstrate remyelinating and nerve growth stimulating properties that lead to restoration of function in animal models of acute spinal cord injury, Geron explains.
FDA placed a clinical hold on the
The firm’s regenerative pipeline includes GRNCM1, an hESC-derived cardiomyocyte treatment in development for the potential treatment of heart disease. The product is currently undergoing large-scale animal testing. Geron is separately developing an hESC-based islet cell therapy GRNIC1 for the treatment of diabetes and is working with collaborators on a degenerative joint disease program based on the development of hESC-derived chondrocytes. The firm says its collaborators aim to start large-scale animal studies with the treatment during 2010.