DiscGenics’ IDCT Research Recognized Among Best in Spine Surgery; Phase III Trial Planned
SALT LAKE CITY, April 9, 2025 /PRNewswire/ — DiscGenics, Inc., a late-stage clinical biopharmaceutical company specializing in allogeneic, cell-based regenerative therapies for musculoskeletal degeneration, announced today that its pivotal study, “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,” has been recognized as one of the top three most influential articles published in the International Journal of Spine Surgery (IJSS) in 2024.
This prestigious recognition highlights the significant clinical impact of the study, which reported the results of the combined Phase I/II clinical trial of IDCT (rebonuputemcel), an allogeneic disc progenitor cell therapy, in patients with symptomatic lumbar degenerative disc disease (DDD). The trial successfully met its primary safety and efficacy endpoints, demonstrating that a single intradiscal injection of high-dose IDCT (9,000,000 cells/mL) safely increased disc volume and produced statistically significant and clinically meaningful improvements in back pain, disability, and quality of life for up to two years post-injection.
“The patient outcomes observed in this study are extremely encouraging, showcasing IDCT’s ability to safely and effectively alleviate pain and disability associated with DDD, while also demonstrating its potential to induce a regenerative effect within the degenerating disc,” stated Matthew F. Gornet, M.D., Board Certified Spine Surgeon at The Orthopedic Center of St. Louis, lead author of the publication, and a leading enroller in the IDCT study.
“We are deeply honored to receive this recognition from ISASS and the IJSS, and we extend our sincere gratitude to Dr. Gornet and all the study authors for their invaluable contributions to this publication,” said Flagg Flanagan, Chief Executive Officer and Chairman of the Board for DiscGenics. “IDCT represents a truly transformative potential in the treatment paradigm for patients suffering from DDD, and the momentum generated by this publication is incredibly inspiring as we finalize preparations to initiate the Phase III clinical trial of this therapy in the United States.”
DiscGenics previously announced that it has received approval from the U.S. Food and Drug Administration (FDA) to proceed with the Phase III clinical evaluation of IDCT. Patient enrollment for the Phase III trial is anticipated to commence in the second quarter of 2025.
About IDCT:
IDCT (injectable disc cell therapy, or rebonuputemcel) is a groundbreaking, standalone, single-injection biologic drug treatment designed to halt the progression of symptomatic lumbar disc degeneration and facilitate the regeneration of the disc from within. The active ingredient (Drug Substance) in IDCT is a live, manufactured progenitor cell population derived from donated adult human intervertebral disc tissue. These cells undergo a rigorous enrichment and expansion process to become Discogenic Cells through a multi-step manufacturing process conducted in a highly controlled environment under current Good Manufacturing Practices (cGMP), resulting in significant cellular proliferation and phenotypic modifications. The Discogenic Cells are subsequently mixed with a viscous Sodium Hyaluronate Solution and excipients to create IDCT, the Final Drug Product. Each lot of IDCT undergoes extensive release testing prior to use, including identity, purity, potency, and safety evaluations. IDCT is cryopreserved and maintained as individual “off-the-shelf” doses for administration via percutaneous injection into the intervertebral disc in an outpatient setting. IDCT has been granted regenerative medicine advanced therapy (RMAT) and Fast Track designations by the U.S. Food and Drug Administration.
https://www.prnewswire.com/news-releases/peer-reviewed-article-reporting-discgenics-cell-therapy-phase-iii-study-results-receives-international-journal-of-spine-surgery-best-paper-award-302424175.html
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