DiscGenics Grabs FDA Fast Track Designation for Cell Therapy
The FDA granted fast track status for DiscGenics’ cell therapy for degenerative disc disease.
The non-invasive treatment, IDCT, is currently being evaluated in two multicenter trials in the U.S. and Japan for treating patients with mild to moderate lumbar DDD. The condition, which isn’t actually a disease, involves pain from one or more deteriorated intervertebral discs that can range from annoying to debilitating.
The company in January announced its U.S. study of the drug-biologic showed safety in the first cohort of patients, with no issues arising from first-time administration.