Creative Medical expands ADAPT trial with 85% enrolled in 15-patient low-opioid cohort

The U.S. Food and Drug Administration approved an amended protocol to enroll an additional 15 patients receiving less than 90 mg of morphine equivalents per day in the ADAPT trial evaluating CELZ-201 (Olastrocel) for chronic lower back pain. This expansion follows the completion of the original cohort and aims to further characterize safety and efficacy in patients with ongoing opioid use.

Enrollment in the new under-90 mg morphine-equivalent cohort has already surpassed 85% and is expected to conclude before the end of summer 2026. The trial leverages a newly implemented AI-driven patient-centric monitoring platform to capture real-time outcome measures and analgesic-use patterns, enhancing data granularity and adherence to electronic diaries.

Interim 180-day data demonstrated statistically significant, clinically meaningful improvements in functional disability (ODI%) and pain scores, with an excellent safety profile and no significant adverse events reported. An independent Data Safety Monitoring Board has reviewed the results favorably and recommended continued advancement of the program.

With positive interim signals and strong enrollment momentum, Creative Medical is preparing for Phase 3 discussions with the FDA focused on a broader chronic lower back pain indication. The company expects to use the expanded dataset to support pivotal trial design and believes the scalable, allogeneic regenerative approach could shift treatment paradigms away from opioids and invasive procedures.