DiscGenics has completed enrolment in its Phase 1/2 first-in-human US clinical study of an allogeneic, injectable Discogenic Cell therapy (IDCT) for degenerative disc disease (DDD).
The prospective, randomised, double-blinded, vehicle- and placebo-controlled, multicentre clinical study is designed to evaluate the safety and efficacy of IDCT in patients with symptomatic, single-level, mild to moderate lumbar DDD. All 60 subjects have been treated and no safety issues have been reported. Subjects will be followed for a period of two years.
“DDD is a complex medical condition characterized by inflammation and breakdown of intervertebral disc tissue, making it a highly complicated environment to heal,” said Domagoj Coric, of Carolina Neurosurgery and Spine Associates and Spine Division Chief of Atrium’s Musculoskeletal Institute (Charlotte, USA), the study’s principal investigator. “We are thrilled to be participating in the clinical evaluation of IDCT, as we believe it has the potential to reduce inflammation and restore disc height, as demonstrated in preclinical studies. If these findings can be replicated in humans, it could result in reduced pain and disability, making IDCT an extremely attractive therapeutic candidate for the unmet medical need of one of the most common causes of chronic low back pain.”
“The completion of patient enrolment in our first-in-human US study of IDCT for DDD represents a significant milestone and an important step in the development of this potentially revolutionary treatment for a truly significant unmet medical need,” said Flagg Flanagan, chief executive officer and chairman of the board of directors for DiscGenics. “We are looking forward to successful completion of the study. In the meantime, we are focused on the scale up and scale out of our commercial cGMP manufacturing facility in Salt Lake City to meet all regulator requirements and anticipated commercial demand for IDCT.”
IDCT is a homologous, allogeneic, injectable cell therapy that utilises proprietary Discogenic Cells, which are biomedically engineered progenitor cells that have been derived from intervertebral disc tissue.