The phase I/II U.S. clinical trial testing DiscGenics' IDCT for treating degenerative disc disease is underway.
Here are five insights.
1. Domagoj Coric, MD, treated the trial's first patient at Charlotte, N.C.-based Carolina Neurosurgery and Spine Associates. Dr. Coric serves as the trial's principal investigator.
2. An allogeneic, non-invasive cell therapy, IDCT includes proprietary Discogenic Cells and a viscous scaffold carrier.
3. The prospective trial is randomized, double-blinded and vehicle- and placebo-controlled. Researchers are testing the therapy's safety and preliminary efficacy at several dosage levels in patients with single-level lumbar DDD.
4. Up to 10 centers will participate in the DiscGenics' trial with about 60 patients.
5. The FDA accepted DiscGenics investigational new drug application for IDCT in the fourth quarter of 2017, allowing the trial to commence.
"If the outcomes observed in human subjects are consistent with preclinical study findings of IDCT, which indicated reduced inflammation and disc height restoration, the result could be reduced pain and disability, offering a truly regenerative therapy for one of the most common causes of chronic low back pain," said Dr. Coric.