DiscGenics Completes Patient Enrollment in Japanese Clinical Study of Cell Therapy for Disc Degeneration as US Study Achieves One-Year Follow-up Milestone
SALT LAKE CITY and TOKYO, April 27, 2021 /PRNewswire/ -- DiscGenics, Inc., a clinical stage biopharmaceutical company focused on developing regenerative cell-based therapies that alleviate pain and restore function in patients with degenerative diseases of the spine, today announced that it has completed enrollment in its Japanese safety study of IDCT, an allogeneic, injectable Discogenic Cell therapy for lumbar disc degeneration, a major cause of chronic low back pain.
This Japanese 38-subject trial is being conducted at seven sites across the Country and passed the first of two planned mid-trial safety reviews by an Independent Data Monitoring Committee (IDMC). All treated subjects will be observed and evaluated for safety, primary efficacy, and secondary outcome measures for a period of six months, at which time another IDMC review will be completed. Per the study protocol, subjects will continue to be followed for a six-month extension period.
"Disc degeneration is a significant unmet medical need among Japan's aging population, and I am pleased to be participating in the clinical evaluation of IDCT as a potential cell therapy to treat this condition," said Dr. Daisuke Sakai, Associate Professor at the Department of Orthopaedic Surgery at Tokai University School of Medicine in Kanagawa, and the study's principal investigator. "In preclinical observations of IDCT's human Discogenic Cells in a canine disc degeneration model, I observed their ability to stop disc height degeneration while improving the structure of the intervertebral disc. If similar results are achieved in humans, the result could be reduced pain and disability associated with disc degeneration."
This prospective, randomized, double-blinded, sham-controlled, multicenter clinical study is designed to evaluate the safety and preliminary efficacy of IDCT in patients with symptomatic, single-level, mild to moderate lumbar disc degeneration. Subjects who met all eligibility criteria were randomized to one of three treatment cohorts. Primary outcome measures include safety and reduction in pain. Secondary outcome measures include reduction in disability and radiographic improvement.
In Japan, IDCT is being investigated under a Clinical Trial Notification (CTN) through the Pharmaceuticals and Medical Devices Agency (PMDA). For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03955315.
Concurrently in the U.S., DiscGenics is conducting an ongoing prospective, randomized, double-blinded, vehicle- and placebo-controlled, multicenter clinical trial of IDCT. All currently enrolled subjects have completed their one-year study visits in our U.S. clinical study of IDCT for lumbar disc degeneration. The study has a one-year extension period, so subjects will continue to be evaluated for safety, primary efficacy, and secondary outcome measures at two additional study visits over the coming year. Through this study, IDCT is being evaluated under an investigational new drug (IND) application through the U.S. Food and Drug Administration (FDA) and will be regulated as a biologic through the Center for Biologics Evaluation and Research (CBER). The U.S. study completed enrollment in Q1 2020, passed all three planned mid-trial safety reviews and has commenced its second year of patient follow-up. For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03347708.
"The achievement of patient enrollment in Japan and our one-year follow-up in the U.S. represent significant milestones for our company and are two very important steps in the development of this potentially regenerative solution for patients suffering from pain associated with disc degeneration," said Flagg Flanagan, Chief Executive Officer and Chairman of the Board of Directors for DiscGenics. "We are deeply appreciative of the commitment the study investigators and hospitals have shown in helping us get to this critical stage and are looking forward to successful completion of both studies."
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SOURCE DiscGenics, Inc.