Creative Medical Technology Holdings, Inc. (CELZ), a clinical-stage biotechnology company, has completed patient enrolment in its FDA-cleared ADAPT clinical trial.
ADAPT is a phase I/II clinical trial evaluating CELZ-201, the company's proprietary perinatal tissue-derived cell therapy for the treatment of chronic lower back pain associated with degenerative disc disease.
CELZ-201, or Olastrocel, is an allogeneic cell therapy that uses healthy donor cells to treat disease or repair tissue in a recipient.
Enrollment completion follows a previously announced positive independent Data Safety Monitoring Board safety review, which confirmed that CELZ-201 demonstrated a favourable safety profile with no significant adverse events and supported continued advancement of the trial.
Chronic back pain is a condition that affects more than 16 million Americans and is valued at up to a multi-billion-dollar market with limited durable, non-surgical solutions.
Now that enrollment is complete, Creative Medical will transition the ADAPT program into its next phase, which focuses on scheduled DSMB reviews, topline safety and efficacy readouts and strategic pathways for late-stage development and commercialisation, including opioid patients.
The company expects to report topline results from the ADAPT trial in the first half of 2026.
CELZ has traded between $1.69 and $6.90 over the past year. On Wednesday, CELZ closed trading at $2.11, up 1.20%.
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