DiscGenics' injectable disc cell therapy, IDCT, passed the initial safety review of its first-in-human trial for moderate degenerative disc disease treatment.
Here are five things to know:
1. The trial is a prospective randomized clinical study to evaluate the safety and efficacy of IDCT in subjects with single-level, symptomatic lumbar intervertebral disc degeneration.
2. The trial is underway at more than 10 centers across the U.S. and will enroll 60 subjects.
3. Each subject receives a single intradiscal injection of his or her assigned treatment into the symptomatic lumbar intervertebral disc. Researchers observe and evaluate subjects for one year, with a one-year extension period.
4. An independent data safety monitoring committee reviewed the first six subjects. The committee reported no safety issues and recommended that the trial continue with no protocol changes.
5. IDCT is DiscGenics' first product candidate. The homologous, allogeneic cell therapy is designed to treat mild to moderate degenerative disc disease using proprietary Discogenic Cells.