The FDA will allow DiscGenics to conduct an investigational new drug study of IDCT.
Here are five key points:
1. A homologous, allogeneic and injectable cell therapy, IDCT leverages proprietary DiscGenic cells to treat degenerative disc disease.
2. Domagoj Coric, MD, of Charlotte, N.C.-based Carolina Neurosurgery and Spine Associates, will serve as the study's principal investigator.
3. The study will be a prospective, randomized, double-blinded, vehicle- and placebo-controlled trial involving multiple centers.
4. The study will include 60 patients suffering from single-level, symptomatic lumbar intervertebral disc degeneration.
5. The company plans to initiate enrollment in the fourth quarter of 2017.
"I am very excited to be participating in the clinical development of this possibly game-changing regenerative therapy for patients with chronic low back pain," said Dr. Coric.