Creative Medical Technology Holdings Reaches Major Clinical Inflection Point with Positive Interim Data from ADAPT Trial and CELZ-201 (Olastrocel) in the Treatment of Chronic Lower Back Pain
PHOENIX, Jan. 13, 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 positive interim 180-day follow-up data from its FDA-cleared ADAPT clinical trial evaluating CELZ-201 (Olastrocel), the Company's proprietary perinatal tissue-derived cell therapy for chronic lower back pain associated with degenerative disc disease.
The study produced statistically significant, clinically meaningful improvements in both functional disability (ODI%) and pain at primary trial end point, confirming durable human efficacy alongside an excellent safety profile.
The announcement of this data follows a previously announced study enrollment completion and positive independent Data Safety Monitoring Board (DSMB) safety review, which confirmed that CELZ-201(Olastrocel) demonstrated a favorable safety profile with no significant adverse events and supported continued advancement of the trial.
"We view this as a major corporate and clinical inflection point for Creative Medical, reflecting the transition of CELZ-201 (Olastrocel) from a clinical program into a promising strategic asset," said Timothy Warbington, President and CEO. "Our focus is execution, data transparency, and unlocking the full value of this platform for patients and shareholders."
Key Clinical Outcomes at Interim Analysis
- ODI% (Functional Disability): Mean improvement of −15.3 percentage points at 180 days (p = 0.0003; large effect size). Approximately 79% of patients achieved clinically meaningful functional improvement.
- Pain (0–10 Scale): Mean reduction of −3.9 points at 180 days (p < 0.00005; large effect size). Approximately 79% of patients achieved ≥2-point pain reduction.
- Safety: Independent DSMB review confirmed no serious adverse events and no treatment-related safety signals, remaining blinded 4:1 treatment: placebo.
Market Opportunity & Differentiation
Chronic lower back pain affects more than 16 million Americans and represents a multi-billion-dollar annual market. Current standards of care rely heavily on opioids, steroid injections, or invasive spine surgery, with limited durable solutions. CELZ-201 (Olastrocel) is an off-the-shelf, allogeneic regenerative cell therapy designed to deliver scalable, consistent, non-surgical, disease-modifying benefit.
Strategic Positioning & Next Catalysts
With safety de-risked and human efficacy signals, CELZ-201 (Olastrocel) is transitioning from execution risk to a data-driven value creation phase. The Company is advancing toward late-stage regulatory engagement, strategic partnership discussions, and commercialization planning awaiting final data.
About Creative Medical Technology Holdings, Inc.
Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ) is a clinical-stage biotechnology company pioneering regenerative medicine therapies derived from adult and perinatal stem cell technologies. The Company's pipeline targets large, underserved markets across orthopedics, immunotherapy, endocrinology, urology, and gynecology, with a mission to deliver scalable, disease-modifying solutions for patients with high unmet medical needs.
For more information, visit www.creativemedicaltechnology.com
Forward-Looking Statements
This press release contains forward-looking statements regarding clinical development, regulatory strategy and positioning, commercialization potential, and market opportunity. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially. Factors include clinical trial outcomes, regulatory decisions, manufacturing considerations, competitive dynamics, and market conditions. Please refer to the Company's filings with the SEC for a discussion of these risks. The Company undertakes no obligation to update forward-looking statements except as required by law.
Investor & Media Contacts
Creative Medical Technology Holdings, Inc.
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Investor Relations
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