The U.S. Food and Drug Administration (FDA) has accepted the clinical protocols for a Phase III clinical program for an allogeneic, injectable disc progenitor cell therapy (IDCT or rebonuputemcel) for painful lumbar degenerative disc disease (DDD).
The FDA acceptance includes the Chemistry, Manufacturing, and Controls (CMC) clinical development plan. It also includes “clinical protocols for parallel pivotal and confirmatory trials.”
Both studies are “randomized, double-blinded, sham-controlled, multicenter studies in subjects with single-level symptomatic lumbar intervertebral disc degeneration.” Each study will last two years including a one-year primary end point and a one-year follow-up period. The pivotal study plans to enroll its first subject during the fourth quarter of 2024.
IDCT is a “standalone, single-injection biologic treatment designed to halt progression of symptomatic lumbar disc degeneration and regenerate the disc from the inside out.” A “live, manufactured progenitor cell population derived from donated adult human intervertebral disc tissue” is the active ingredient in IDCT. Utilizing a multi-step manufacturing process, the cells are “enriched and expanded.” The process results in “significant proliferation and phenotypic changes to the cells.”
Once the manufacturing process is completed, “the Discogenic Cells are subjected to extensive testing” and are then “mixed with a viscous Sodium Hyaluronate Solution and excipients to generate IDCT.” IDCT is “cryopreserved and maintained as individual ‘off-the-shelf’ doses for administration via percutaneous injection into the intervertebral disc in an outpatient setting.”
DiscGenics, Inc. is developing the investigational product. DiscGenics, based in Salt Lake City, Utah, is a privately held, biopharmaceutical company. It develops allogeneic, cell-based, regenerative therapies for patients with painful degenerative diseases of the spine. Its focus is on both pain relief and function restoration.
Director of Evidence-Based Pain Medicine Research and Education, Department of Pain Management at the Cleveland Clinic Nagy Mekhail, M.D., Ph.D. is participating in the clinical evaluation. Dr. Mekhail commented, “There are very few credible treatments on the market for mechanical back pain, and we believe early clinical evidence suggests DiscGenics’ cell therapy has the potential to shift the paradigm of care from ablative/destructive procedures or fusion surgery to a revolutionary regenerative and minimally invasive treatment for patients suffering from painful degenerative disc disease.”
Dr. Mekhail continued, “We look forward to participating in the continued clinical evaluation of this long waited for, promising therapy.”
