DiscGenics, a clinical stage regenerative medicine company, has announced the first patient has been treated in its phase I/II US clinical trial of IDCT for mild-to-moderate degenerative disc disease. The treatment took place at Carolina Neurosurgery and Spine Associates in Charlotte, USA, led by the study’s principal investigator, Domagoj Coric (Charlotte, USA).
IDCT is an allogeneic (donor-derived), non-invasive cell therapy comprised of proprietary discogenic cells and a viscous scaffold carrier. This prospective, randomised, double-blinded, vehicle- and placebo-controlled study is designed to evaluate the safety and preliminary efficacy of IDCT at varying dosage levels in subjects with single-level, symptomatic lumbar degenerative disc disease, a major cause of chronic low back pain.
Coric says, “We are thrilled to be participating in the clinical evaluation of this potentially game-changing therapy for patients with degenerative disc disease. 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.”
“Commencing clinical evaluation of our first product candidate is a critical milestone for DiscGenics as we continue to advance IDCT as a potentially revolutionary treatment for degenerative disc disease,” says Flagg Flanagan, CEO and chairman of the board of directors for DiscGenics. “The millions of patients who suffer from low back pain every year currently have limited treatment options, one of which is opioid use for pain management. If proven effective, IDCT could be a vital tool for curtailing opioid addiction among those who suffer from this debilitating condition.”
The trial will take place in up to 10 centers across the US and will enroll approximately 60 subjects. Those who meet all eligibility criteria will be randomised to one of four treatment cohorts: low dose IDCT (n=20), high dose IDCT (n=20), vehicle (n=10) and placebo (n=10).
Each subject will receive a single intradiscal injection of his or her assigned treatment into the target symptomatic lumbar intervertebral disc. Following treatment, subjects will be observed and evaluated for a period of one year, with a one-year extension period.