DiscGenics Completes Enrollment in Discogenic Cell Therapy Clinical Trial

By Julie A. Vetalice

DiscGenics Completes Enrollment in Discogenic Cell Therapy Clinical Trial

DiscGenics completed enrollment in its Phase I/II first-in-human U.S. clinical study of injectable disc cell therapy (IDCT), an allogeneic treatment for degenerative disc disease (DDD).

The two-year prospective, randomized, double-blinded, vehicle- and placebo-controlled, multicenter clinical study will examine IDCT in patients with symptomatic, single-level, mild to moderate lumbar DDD. All 60 subjects have been treated with no reported safety issues.

Eligible subjects were randomized to one of four treatment cohorts: low dose IDCT (n=20), high dose IDCT (n=20), vehicle (n=10) and placebo (n=10). Each subject received a single intradiscal injection of his or her assigned treatment into the target symptomatic lumbar intervertebral disc. Primary outcome measures include safety and reduction in pain; secondary outcome measures include reduction in disability and radiographic improvement.

IDCT is also being evaluated in a multicenter safety study in Japan.

Product Labels: PRP/Cell-Based/Osteoinductive Materials

Tags: ["Trial\/Study"]