DiscGenics today announced the first patients have been treated in its 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, Japan, led by Daisuke Sakai, associate professor at the Department of Orthopaedic Surgery and the study’s principal investigator.
IDCT is a homologous, allogeneic, injectable cell therapy that utilises 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.
This prospective, randomised, double-blinded, sham-controlled study is 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.
“I am excited to be participating in the clinical evaluation of IDCT as a potential cell therapy to treat degenerative disc disease,” said Sakai. “I am encouraged by my preclinical observations of IDCT’s human Discogenic Cells in a canine disc degeneration model that demonstrated the ability to stop disc height degeneration while improving the structure of the intervertebral disc. If we can achieve similar results in human subjects, the result could be reduced pain and disability associated with DDD.”
Initiation of this trial was supported by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA) approval of a Clinical Trial Notification (CTN) application for IDCT, announced in the fourth quarter of 2018.
The trial will take place in six centers across Japan and will enrol 38 subjects. Those who meet all eligibility criteria will be randomised 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 a period of six months, with a six-month extension period.
For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03955315.