DiscGenics completed enrollment in its Japanese safety study of allogeneic, injectable discogenic cell therapy (IDCT).
This prospective, randomized, double-blinded, sham-controlled, multicenter clinical study is designed to evaluate IDCT in patients with symptomatic, single-level, mild to moderate lumbar disc degeneration.
Concurrently in the U.S., DiscGenics is conducting an ongoing prospective, randomized, double-blinded, vehicle- and placebo-controlled, multicenter clinical trial of IDCT. All currently enrolled subjects have completed their one-year study visits. Through this study, IDCT is being evaluated under an investigational new drug application. The U.S. study completed enrollment in 1Q20.
"The achievement of patient enrollment in Japan and our one-year follow-up in the U.S. represent significant milestones for our company and are two very important steps in the development of this potentially regenerative solution for patients suffering from pain associated with disc degeneration," said Flagg Flanagan, Chief Executive Officer of DiscGenics. "We are deeply appreciative of the commitment the study investigators and hospitals have shown in helping us get to this critical stage and are looking forward to successful completion of both studies."