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.