DiscGenics announced today that its groundbreaking research on a cell-based therapy for degenerative disc disease has received prestigious recognition from the International Journal of Spine Surgery (IJSS), as the company prepares to launch Phase III clinical trials.
The peer-reviewed article, "Allogeneic Disc Progenitor Cells Safely Increase Disc Volume and Improve Pain, Disability, and Quality of Life in Patients With Lumbar Disc Degeneration—Results of an FDA-Approved Biologic Therapy Randomized Clinical Trial," was selected as one of just three of the best and most influential articles published in IJSS in 2024.
The publication reported results from the combined Phase I/II clinical study of injectable disc cell therapy (IDCT, also known as rebonuputemcel) for painful lumbar degenerative disc disease (DDD). The study met both primary safety and efficacy endpoints, demonstrating that a single intradiscal injection of high-dose IDCT (9,000,000 cells/mL) safely increases disc volume while producing statistically significant and clinically meaningful improvements in back pain, disability, and quality of life up to two years post-injection.
"The patient outcomes from this study are very encouraging, as they show IDCT's ability to safely and effectively reduce pain and disability associated with DDD while also demonstrating the potential of this treatment to produce a regenerative effect within the degenerating disc," said Matthew F. Gornet, MD, Board Certified Spine Surgeon at The Orthopedic Center of St. Louis, lead author, and top enroller in the IDCT study.
Dr. Gornet will present the research at the International Society for the Advancement of Spine Surgery (ISASS) meeting in Miami, Florida, on Friday, April 11.
Advancing to Phase III Clinical Trials
DiscGenics has received approval from the U.S. Food and Drug Administration (FDA) to proceed with Phase III clinical evaluation of IDCT. Subject enrollment is expected to begin in Q2 2025, marking a significant milestone in the development of this potential breakthrough therapy.
"We are honored to be recognized by ISASS and the IJSS and would like to thank Dr. Gornet and all of the study authors for their contributions to this article," said Flagg Flanagan, Chief Executive Officer and Chairman of the Board for DiscGenics. "IDCT truly has the potential to change the paradigm of care for patients with DDD, and the momentum provided by this publication has been inspiring as we finalize preparations to initiate Phase III clinical study of this therapy in the U.S."
Understanding IDCT and Its Potential Impact
Degenerative disc disease affects millions of people worldwide, causing chronic back pain, disability, and reduced quality of life. Current treatment options are limited, often focusing on symptom management rather than addressing the underlying degeneration.
IDCT represents a novel approach as a standalone, single-injection biologic drug treatment designed to halt progression of symptomatic lumbar disc degeneration and regenerate the disc from the inside out. The active ingredient is a live, manufactured progenitor cell population derived from donated adult human intervertebral disc tissue.
These cells undergo a sophisticated manufacturing process in a highly controlled environment under current Good Manufacturing Practices (cGMP), resulting in significant proliferation and phenotypic changes. The final product is mixed with a viscous Sodium Hyaluronate Solution and excipients to generate IDCT, which is then cryopreserved and maintained as individual "off-the-shelf" doses for administration via percutaneous injection in an outpatient setting.
The FDA has granted IDCT both regenerative medicine advanced therapy (RMAT) and Fast Track designations, highlighting the therapy's potential significance in addressing this unmet medical need.
Manufacturing and Development Strategy
To maintain control over compliance, cost, and production timelines, DiscGenics has built and validated an in-house scalable, allogeneic cell manufacturing process and cGMP facility at its headquarters in Salt Lake City, Utah. This strategic approach allows the company to oversee the entire development process for its novel therapies.
Beyond IDCT, DiscGenics is also developing a follow-on allogeneic cell platform to enable new musculoskeletal indications, potentially expanding the impact of their regenerative medicine approach to other conditions.
As a privately held, late-stage clinical biopharmaceutical company, DiscGenics continues to advance its mission of developing allogeneic, cell-based regenerative therapies for musculoskeletal degeneration, with IDCT leading the way as its flagship product candidate.
