DiscGenics principal investigator Domagoj Coric, MD, of Carolina Neurosurgery and Spine Associates in Charlotte, N.C., treated the first patient in the phase 1/phase 2 clinical trial of IDCT.
Here are five things to know.
1. The clinical trial is testing developing cell therapies for treating mild to moderate degenerative disc disease.
2. IDCT is an allogeneic, noninvasive cell therapy comprised of discogenic cells and a viscous scaffold carrier. The study is designed to evaluate safety and preliminary efficacy of IDCT at different dosage levels in patients with single-level, symptomatic lumbar degenerative disc disease.
3. DiscGenics plans to introduce the trial at 10 centers across the U.S. and enroll roughly 60 patients. Patients who meet criteria will be randomly divided into four treatment cohorts.
4. All patients will receive a single intradiscal injection of the assigned treatment into the lumbar intervertebral disc.
5. After the treatment, patients will be followed and evaluated for one year, with an one-year extension period.