CELZ's ADAPT Trial Achieves Full Enrollment—What's Next for Chronic Back Pain Treatment?

Creative Medical Technology Holdings, Inc. (CELZ) has successfully wrapped up patient enrollment in its FDA-cleared ADAPT trial, marking a significant milestone in the development of CELZ-201, also known as Olastrocel. This phase I/II clinical trial is evaluating an innovative allogeneic cell therapy derived from perinatal tissue, designed to address chronic lower back pain stemming from degenerative disc disease.

The Unmet Medical Need

Chronic lower back pain affects over 16 million Americans, representing a multi-billion-dollar market with surprisingly few durable non-surgical treatment options. Most patients are left managing their condition through limited alternatives, creating a genuine demand for breakthrough therapies. CELZ-201 operates as a perinatal tissue-derived cell therapy, utilizing healthy donor cells to repair damaged tissue and restore function in recipients—an approach that exemplifies the creative symbols of modern regenerative medicine.

Safety Profile Confirmed

The enrollment completion follows a positive independent Data Safety Monitoring Board safety review, which validated that CELZ-201 demonstrated a favorable safety profile with no significant adverse events. This clearance paves the way for the trial to progress into its next phase without safety concerns holding it back.

What Comes Next

With enrollment now closed, Creative Medical is transitioning the ADAPT program toward its next stage. This phase will include scheduled DSMB reviews, topline safety and efficacy readouts, and exploration of strategic pathways for late-stage development and commercialization—including potential applications in opioid-dependent patient populations. The company expects to report topline results from the ADAPT trial in the first half of 2026.

Market Context

CELZ stock has fluctuated between $1.69 and $6.90 over the past year. Most recently, the stock closed trading on Wednesday at $2.11, up 1.20%. The completion of ADAPT enrollment represents a tangible step forward in the company’s clinical development timeline, potentially positioning it favorably for future market opportunities in regenerative cell therapy.