Salt Lake City-based DisGeneics, Inc. announced the first patients have been treated in the Japanese safety study, a clinical trial of IDCT for mild to moderate degenerative disc disease (DDD). The treatments took place at Tokai University School of Medicine in Kanagawa, led by Dr. Daisuke Sakai, Associate Professor at the Department of Orthopedic Surgery and the study’s principal investigator.
DDD is a painful, chronic and progressive disease that is characterized by inflammation and breakdown of extracellular matrix within the intervertebral disc. The condition is estimated to affect more than one million people, including 200,000 patients needing surgical intervention every year in Japan. Current treatment options for DDD are limited to physical rehabilitation programs and pain management, in the earlier stages. In the more advanced stages, oftentimes a patient’s only option is surgical intervention to remove the painful disc(s), fuse two or more vertebral bones and/or replace bone or tissue altogether. However, back surgeries often have limited success and may result in subsequent adjacent level degeneration.
Injectable Disc Cell Therapy (IDCT) is a non-surgical study treatment for degenerative disc disease. More IDCT is a homologous, allogeneic, injectable cell therapy that utilizes biomedically engineered progenitor cells, known as Discogenic Cells, that have been derived from intervertebral disc tissue to offer a non-surgical, potentially regenerative solution for the treatment of mild to moderate DDD.
The study is a prospective, randomized, double-blinded, sham-controlled study designed to evaluate the safety and preliminary efficacy of IDCT at two dosage levels in subjects with single-level, symptomatic lumbar DDD, a major cause of chronic low back pain.
Initiation of this trial was supported by the Japanese and Medical Devices Agency (PMDA) approved of a Clinical Trial Notification (CTN) application for IDCT announced in Q4 2018.
The trial will occur in six research sites across Japan and will enroll 38 subjects. Those who meet all eligibility criteria will be randomized to one of three treatment cohorts: low dose IDCT (n=15), high dose IDCT (n=15) and sham (n=8).
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 six months, with a six-month extension period.
Dr. Daisuke Sakai, Associate Professor at the Department of Orthopedic Surgery