DiscGenics has announced that the US Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to Injectable Disc Cell Therapy (IDCT or rebonuputemcel), an injectable, allogeneic discogenic progenitor cell therapy for the treatment of symptomatic lumbar degenerative disc disease (DDD).
Flagg Flanagan, chief executive officer and chairman of the board for DiscGenics, said: “This designation represents a critical validation of our novel approach to utilising a manufactured live progenitor cell population derived from donated adult human intervertebral disc tissue to treat disc degeneration.
“As committed stewards of this technology, we look forward to partnering with the FDA to expedite our drug development program and to ultimately realising the potential of IDCT to address the unmet medical needs of millions of patients with this painful and debilitating condition.”
The RMAT designation is based on positive two-year clinical data from DiscGenics’s first-in-human study of IDCT. The study demonstrated IDCT’s potential to safely increase disc volume and provide rapid, durable improvements in low back pain, function, quality of life, and pain medication usage out to two years’ post-injection in patients with lumbar DDD, say the company.
According to DiscGenics, IDCT is the first and only product intended for spine care to receive this designation.