PHOENIX, June 22, 2026 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) ("Creative Medical" or the "Company") , a clinical-stage biotechnology company advancing regenerative medicine solutions, today announced that the U.S. Food and Drug Administration (FDA) has cleared an expansion of the Company’s FDA-cleared ADAPT clinical trial evaluating CELZ-201 (Olastrocel) for chronic lower back pain associated with degenerative disc disease. Under the amended protocol, the Company is enrolling an additional 15 patients receiving less than 90 mg per day in morphine equivalents to further characterize safety and efficacy in patients with ongoing opioid use associated with the treatment of chronic lower back pain. The new cohort is already more than 85% enrolled and leverages the Company’s newly implemented, patient-centric AI pain medication monitoring system to capture rapid, accurate patient-reported outcome measures and analgesic-use patterns in real time. This expansion follows previously reported completion of enrollment in the original ADAPT study population and positive interim 180-day data demonstrating statistically significant, clinically meaningful improvements in functional disability (ODI%) and pain, together with an excellent safety profile. The trial remains supported by a favorable independent Data Safety Monitoring Board (DSMB) review, which reported no significant adverse events and recommended continued advancement of the program. “The FDA’s clearance of this expansion cohort represents another important step in the clinical and strategic maturation of Olastrocel,” said Timothy Warbington, President and CEO of Creative Medical Technology. “With enrollment in our original ADAPT population completed, encouraging safety and efficacy signals, and the new less-than-90 mg morphine-equivalent cohort already largely enrolled, we believe we are rapidly building a robust, real-world data package around chronic lower back pain patients who urgently need non-opioid, disease-modifying options. “We are now actively preparing for Phase 3 discussions with the FDA focused on a broader chronic lower back pain indication,” Mr. Warbington continued. “Our priority is disciplined execution: completing this expansion cohort, fully leveraging our AI-enabled, patient-centric monitoring platform, and positioning Olastrocel as a scalable, allogeneic regenerative solution in a market that still relies heavily on opioids, injections and invasive surgery. We believe this strategy has the potential to create significant value for patients and for our shareholders as we transition from a purely clinical story to a data-driven, late-stage development opportunity.” Clinical and Technology Highlights ADAPT trial momentum: The ADAPT study previously met its interim 180-day endpoints with statistically significant and clinically meaningful reductions in functional disability (ODI%) and pain, alongside an excellent safety profile. Original cohort completed: Enrollment of the original FDA-cleared cohort was completed in December 2025 following a positive DSMB safety review. New under-90 mg morphine-equivalent cohort: The newly cleared cohort of 15 patients focuses on individuals receiving less than 90 mg morphine equivalents per day, providing a controlled view into Olastrocel’s performance in patients with ongoing but moderate opioid use. Rapid enrollment: Enrollment of this expansion cohort is already greater than 85%, and the Company anticipates completing enrollment before the end of summer 2026. AI-enabled monitoring: The expansion cohort incorporates the Company’s new AI-driven pain medication monitoring and patient-reported outcome system, designed to enhance data granularity, improve adherence to electronic diaries, and accelerate high-quality data capture for both pain and functional endpoints. Addressing a Persistent Opioid and Chronic Pain Crisis Chronic lower back pain remains one of the most common and disabling conditions in the United States, with limited durable treatment options for many patients. Current treatment pathways often include physical therapy, oral analgesics, steroid injections, chronic opioid use or invasive spine procedures, yet many patients continue to experience persistent pain and functional impairment. Drug overdose remains one of the nation’s most urgent public health challenges, and opioids continue to account for the majority of overdose deaths in the United States. Creative Medical believes the development of new non-opioid therapeutic approaches for chronic pain remains a critical medical and societal priority. Olastrocel (CELZ-201) is designed as an off-the-shelf, allogeneic regenerative cell therapy intended to deliver a scalable, non-surgical treatment option for patients with chronic lower back pain associated with degenerative disc disease. The therapy is administered via a minimally invasive, ultrasound-guided intramuscular procedure. Financial and Operational