Creative Medical Technology Holdings, Inc., announced that the US Food and Drug Administration has cleared an expansion of the company's ADAPT clinical trial evaluating CELZ-201 (Olastrocel) in patients with chronic lower back pain associated with degenerative disc disease, according to a press release from the company.
Under the amended protocol, the company is enrolling an additional 15 patients receiving less than 90 mg of morphine-equivalent opioids per day to further characterize the safety and efficacy of Olastrocel in patients with ongoing opioid use. The company reported that the new cohort is already more than 85% enrolled and expects enrollment to be completed by the end of summer 2026.
The expansion follows completion of enrollment in the original ADAPT study population. According to the company, interim 180-day results demonstrated statistically significant and clinically meaningful improvements in pain and functional disability, and a favorable safety profile. The company also reported that an independent Data Safety Monitoring Board identified no significant adverse events and recommended continued advancement of the program.
Creative Medical stated that the expansion cohort incorporates an artificial intelligence-based monitoring platform designed to collect patient-reported outcomes and analgesic-use patterns in real time. According to the company, the system is designed to improve electronic diary adherence and accelerate data collection for pain and functional endpoints.
The company describes Olastrocel as an allogeneic, perinatal tissue-derived regenerative cell therapy candidate designed as an off-the-shelf treatment for chronic lower back pain associated with degenerative disc disease. The therapy is administered through a minimally invasive, ultrasound-guided intramuscular procedure.
Timothy Warbington, president and chief executive officer of Creative Medical Technology, said, “We are now actively preparing for Phase 3 discussions with the [US Food and Drug Administration] focused on a broader chronic lower back pain indication.” According to the company, those discussions are expected to address the design of a potential pivotal program and the evaluation of CELZ-201 in a broader chronic lower back pain population.
Creative Medical stated that it expects to complete enrollment in the expansion cohort using existing resources and plans to use data from the expanded cohort together with existing ADAPT safety and efficacy data to support regulatory planning and Phase 3 discussions with the US Food and Drug Administration.