DiscGenics, a biopharmaceutical company focused on regenerative therapies for spinal conditions, has finished enrolling patients in its Japanese study of IDCT, an allogeneic, injectable disc cell therapy for lumbar disc degeneration.
Thirty-eight subjects with single-level, mild to moderate lumbar degenerative disc disease will be evaluated for safety, primary efficacy and secondary outcome measures over six months. Participants will continue to be followed for a six-month extension period.
"In preclinical observations of IDCT's human discogenic cells in a canine disc degeneration model, I observed their ability to stop disc height degeneration while improving the structure of the intervertebral disc," Dr. Daisuke Sakai, the study's principal investigator, said in an April 26 news release. "If similar results are achieved in humans, the result could be reduced pain and disability associated with disc degeneration."
DiscGenics' U.S. clinical trial of IDCT treated all 60 subjects and reported no safety issues, according to the company. All subjects completed one-year follow-ups in the U.S. study, which has a one-year extension period.