The Japanese Pharmaceuticals and Medical Devices Agency (PMDA) has approved a Clinical Trial Notification (CTN) application for IDCT (DiscGenics), an allogenic injectable disc cell therapy for the treatment of degenerative disc disease (DDD).
IDCT is available off-the-shelf and offers a non-surgical therapeutic option for patients suffering from DDD. The CTN approval allows DiscGenics to advance IDCT into clinical studies in Japan.
DiscGenics intends to initiate a prospective, double-blinded, sham-controlled, multicentre clinical study to evaluate the safety and preliminary efficacy of IDCT in Japanese patients with painful, single-level lumbar DDD. The 38-patient trial is expected to begin enrolling in Japan in the first half of 2019.
“I recently participated in a preclinical study of IDCT’s human discogenic cells in a canine disc degeneration model here in Japan, and was pleased to observe the cells’ ability to stop disc height degeneration while improving the structure of the intervertebral disc,” said Daisuke Sakai, associate professor at the Department of Orthopaedic Surgery and the Tokai University School of Medicine (Kanagawa, Japan) and the study’s principal investigator.
He continued: “If similar results can be demonstrated in human subjects, the result could be reduced pain and disability associated with one of the most common causes of chronic low back pain.”
Discogenic cells are highly specialised progenitor cells that have been engineered from donated adult human intervertebral disc tissue, and are the therapeutic engine behind IDCT. A research article summarising results from Sakai’s study of discogenic cells in the canine disc degeneration model was recently published in the Journal of Orthopaedic Research Spine.
DiscGenics is leveraging the accelerated regenerative medicine pathway created by the Japanese Pharmaceuticals and Medical Devices Act (a revision of the Pharmaceutical Affairs Act) to pursue regulatory approval of IDCT in Japan, and has been working closely with the PMDA through a series of consultations to satisfy all requirements for trial design and materials safety.
DiscGenics is also conducting an ongoing Phase I/II prospective, randomised double-blinded, vehicle- and placebo-controlled, multicentre clinical study of IDCT in the USA among subjects with single-level, symptomatic lumbar DDD. Through this study, IDCT is being evaluated under an investigational new drug (IND) allowance by the US Food and Drug Administration (FDA) and will be regulated as a drug-biologic through a therapeutics biologics application (BLA).