Creative Medical Technology Holdings has completed enrollment and treatment of every patient in its FDA-cleared ADAPT clinical trial of CELZ-201, also known as Olastrocel, in a key turning point for the company’s effort to develop a regenerative treatment for chronic lower back pain.

 

The completion includes the trial’s original cohorts as well as an expanded cohort of patients with ongoing opioid use. Creative Medical said the milestone moves ADAPT out of active recruitment and treatment and into patient follow-up, data analysis and regulatory planning.

 

The company says the transition should also reduce near-term trial expenses tied to recruitment, screening, enrollment and treatment, potentially helping preserve cash and extend its operating runway as it prepares for the next stage of development.

 

“Completing enrollment and treatment across the entire ADAPT trial, including the opioid cohort, is a defining achievement for Creative Medical and for the Olastrocel program,” said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. 

 

“We believe the totality of data generated to date - including favorable safety observations, encouraging early efficacy signals and the ability to treat patients with ongoing opioid use -positions us to advance toward RMAT evaluation and prepare for Phase 3 discussions with the FDA for a broader chronic lower back pain population.”

 

ADAPT is evaluating Olastrocel, a perinatal tissue-derived, allogeneic regenerative cell therapy candidate, in patients with chronic lower back pain associated with degenerative disc disease.

 

The treatment is administered through a minimally invasive, ultrasound-guided intramuscular procedure. Olastrocel remains investigational and has not been approved by the U.S. Food and Drug Administration for any indication.

 

Creative Medical said an independent Data Safety Monitoring Board previously found a favorable safety profile, with no significant adverse events or treatment-related safety signals reported to date.

 

Interim 180-day results have also shown improvements in pain and functional disability, according to the company.

 

The reported data include a mean 15.3-point improvement in ODI functional-disability scores, with about 79% of patients achieving clinically meaningful functional improvement. Patients also reported a mean 3.9-point reduction on a 0-to-10 pain scale, with approximately 79% achieving at least a two-point reduction.

 

The company says the completed treatment population, combined with the interim findings, provides the foundation for its next regulatory steps.

 

“Importantly, with enrollment and treatment now complete, we expect ADAPT-related clinical execution costs to decrease as we move into follow-up, data analysis and regulatory preparation. This should allow us to preserve capital, extend our operating runway and continue advancing Olastrocel in a highly disciplined manner. 

 

"We believe this is exactly the type of milestone investors want to see: strong clinical execution, positive early signals, reduced near-term trial execution burden and a clearer path toward late-stage regulatory engagement.

 

“Chronic lower back pain remains one of the most significant drivers of disability, opioid exposure and healthcare utilization in the United States,” Warbington added. 

 

“Patients and physicians urgently need durable, scalable, non-surgical and non-opioid options. Olastrocel was developed to address that need, and we believe ADAPT is moving us closer to a potential new treatment paradigm for patients who have too few meaningful alternatives today.”

 

The final expansion cohort focused specifically on patients who continue to use opioids, a population Creative Medical says reflects an important part of the real-world chronic lower back pain market.

 

The FDA cleared the expansion in June 2026. All patients in the cohort have now been enrolled and treated, with follow-up continuing.

 

The company is collecting patient-reported outcomes, pain-medication data, functional assessments and safety information.

 

“The completion of treatment in the opioid cohort is particularly important because it allows us to evaluate Olastrocel in a clinically relevant population where the unmet need is significant,” said Warbington. 

 

“The opioid crisis continues to highlight the limitations of current chronic pain management, and our goal is to generate the type of rigorous data needed to support a differentiated, non-opioid regenerative therapy for patients suffering from chronic lower back pain.”

 

With treatment complete, Creative Medical is turning its attention to a potential Regenerative Medicine Advanced Therapy designation and discussions with the FDA over a Phase 3 program targeting a broader chronic lower back pain population.

 

The company’s priorities now include completing follow-up, analyzing safety and efficacy data, assessing opioid-use outcomes and preparing for potential FDA engagement.

 

“ADAPT is no longer just an enrollment story - it is now a data, regulatory and execution story,” Warbington said.