Creative Medical completes ADAPT trial enrolment for Olastrocel

Creative Medical Technology Holdings has completed enrolment and treatment across all cohorts of its ADAPT clinical trial, evaluating the regenerative cell therapy candidate CELZ-201, also known as Olastrocel, in patients with chronic lower back pain associated with degenerative disc disease. The NASDAQ-listed company said all patients in both the original FDA-cleared study and the subsequently cleared opioid expansion cohort have now received treatment.

The programme transitions from an active enrolment and treatment phase into patient follow-up, data collection and regulatory preparation. Creative Medical said it expects the shift to reduce near-term clinical execution costs and extend its operating runway as it prepares for potential Regenerative Medicine Advanced Therapy (RMAT) designation evaluation and Phase 3 discussions with the FDA.

Trial data to date

Interim 180-day data from the original ADAPT cohorts, reported previously, showed a mean improvement in Oswestry Disability Index score of 15.3 percentage points, with approximately 79% of patients achieving clinically meaningful functional improvement. On a standard 0–10 pain scale, patients reported a mean reduction of 3.9 points at 180 days, with a similar proportion achieving at least a two-point reduction. An independent Data Safety Monitoring Board confirmed no serious adverse events and no treatment-related safety signals.

Olastrocel is designed as an allogeneic, off-the-shelf therapy derived from perinatal tissue, administered via a minimally invasive, ultrasound-guided intramuscular procedure. The company says the candidate is intended to address inflammation and tissue-degeneration pathways without the systemic exposure associated with opioid analgesics or the recovery burden of spinal surgery.

Timothy Warbington, president and chief executive of Creative Medical, said the completed opioid-cohort treatment was "particularly important because it allows us to evaluate Olastrocel in a clinically relevant population where the unmet need is significant."

Regulatory path and market context

Creative Medical is now assessing whether the maturing ADAPT dataset may support a formal RMAT designation request. The FDA's RMAT pathway is designed for regenerative therapies targeting serious conditions with preliminary clinical evidence of potential to address unmet need; designation can confer rolling review, early FDA interaction and potential for accelerated approval. The company has not yet filed a Phase 3 protocol or confirmed a Phase 3 start date.

The chronic lower back pain market is large and contested. Current standard-of-care options including physiotherapy, corticosteroid injections, oral analgesics and spinal fusion surgery leave a substantial proportion of patients with persistent pain and functional limitation, which has sustained interest in regenerative and cell-based approaches. A number of academic-spinout and clinical-stage companies are pursuing intradiscal and intramuscular cell therapy routes for degenerative disc disease, though no regenerative cell therapy has yet reached regulatory approval in this indication in the United States or Europe.

Creative Medical's positioning of Olastrocel as a non-surgical, non-opioid option is commercially coherent given the sustained policy pressure on opioid prescribing in the US, but the interim data remain early-stage and the company has not disclosed the full dataset, a powered Phase 3 design, or a primary endpoint proposal for late-stage trials. Investors and clinicians will need to see maturing follow-up data and a credible regulatory strategy before the programme's differentiation can be fully assessed.

The company remains investigational-stage; Olastrocel has not received FDA approval for any indication, and safety and efficacy have not been formally established.