Clinical stage biopharmaceutical company DiscGenics has completed patient enrolment in its Phase I / Phase II first-in-human US clinical study of injectable discogenic cell therapy (IDCT) to treat degenerative disc disease (DDD).
The allogeneic therapy uses proprietary discogenic cells, which are biomedically engineered progenitor cells derived from intervertebral disc tissue.
DiscGenics’ study aims to analyse the safety and preliminary efficacy of IDCT in patients with symptomatic, single-level, mild to moderate lumbar intervertebral disc degeneration.
The company claimed that no safety issues have been reported to date in any of the 60 subjects treated under the prospective, randomised, double-blinded, vehicle and placebo-controlled multi-centre clinical study.
Subjects of the trail have been screened and verified to have met all eligibility criteria for enrolment, including early to moderate symptomatic, single-level DDD from L3-S1, and no previous lumbar spine surgery.
Safety and reduction in pain are cited as the primary outcome measures of the trail. The secondary outcome measures include a decrease in disability and radiographic improvement.
DiscGenics board of directors CEO and chairman Flagg Flanagan said: “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.
“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.”
The trial is currently in progress in 14 centres across 12 US states.
IDCT is also being analysed in a multi-centre safety study in Japan supported by a Clinical Trial Notification. It is approved by the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).