DiscGenics Entering Clinical Trial in Japan for Disc Cell Therapy

By Julie A. Vetalice

DiscGenics received approval in Japan to advance into clinical studies of IDCT allogeneic injectible disc cell therapy for the treatment of lumbar degenerative disc disease.

The prospective, double-blinded, sham-controlled, multicenter study will evaluate the safety and preliminary efficacy of IDCT in Japanese patients. The 38-patient trial is slated to begin enrollment in 1H19.

IDCT is an allogeneic cell therapy comprising Discogenic Cells and a viscous scaffold. During treatment, a dose of IDCT is injected percutaneously into the disc.

The company is also conducting an ongoing Phase I/II prospective, randomized double-blinded, vehicle- and placebo-controlled, multicenter clinical study of IDCT in the U.S., with the first patient treated in 2Q18. The prospective, randomized, double-blinded, vehicle- and placebo-controlled 10-center trial will enroll 60 subjects, evaluating safety and preliminary efficacy of IDCT at varying dosage levels.

Source: DiscGenics

Product Labels: PRP/Cell-Based/Osteoinductive Materials

Tags: Regulatory