Creative Medical Technology Holdings, Inc. Completes Enrollment in FDA-Cleared ADAPT Trial for CELZ-201-Olastrocel, Marking Major Clinical Inflection Point
PHOENIX, Dec. 17, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ), a clinical-stage biotechnology company advancing regenerative medicine solutions, today announced the successful completion of patient enrollment in its FDA-cleared ADAPT clinical trial evaluating CELZ-201 (Olastrocel), the Company's proprietary perinatal tissue-derived cell therapy for the treatment of chronic lower back pain associated with degenerative disc disease.
Enrollment completion follows a previously announced positive independent Data Safety Monitoring Board (DSMB) safety review, which confirmed that CELZ-201 demonstrated a favorable safety profile with no significant adverse events and supported continued advancement of the trial.
With enrollment now complete, CELZ has reached a critical execution milestone, transitioning the ADAPT program into its next phase focused on follow-up, and data analysis. Company leadership, investigators, and clinical partners expressed strong enthusiasm as CELZ advances toward what management believes could represent a paradigm shift in the treatment of chronic back pain, a condition impacting more than 16 million Americans and representing a multi-billion-dollar market with limited durable, non-surgical solutions.
"This is a defining moment for Creative Medical Technology," said Timothy Warbington, President and CEO. "Completing enrollment in the ADAPT trial validates our execution capabilities and underscores the excitement surrounding CELZ-201 among clinicians and patients alike. With enrollment behind us, we are now firmly positioned to generate meaningful clinical data that could fundamentally change how chronic lower back pain is treated—without surgery and without lifelong opioid dependence."
Building on a Strong Foundation of Safety, IP, and Human Data
The ADAPT trial (CELZ-201-ADAPT-2023) is a randomized, double-blind, placebo-controlled, dose-escalation study designed to evaluate the safety, tolerability, and preliminary efficacy of CELZ-201 delivered via a minimally invasive, ultrasound-guided intramuscular procedure. The study incorporates rigorous safety oversight, including DSMB reviews and adverse event tracking aligned with CTCAE v5.0 standards.
"These data points are not theoretical—they represent real patients experiencing real relief," Warbington added. "ADAPT is designed to rigorously confirm what our earlier work has already strongly suggested: CELZ-201 has the potential to deliver durable, disease-modifying benefit in a space desperate for innovation."
A Large, Underserved Market with Clear Differentiation
Chronic lower back pain remains one of the leading causes of disability worldwide, often managed with invasive surgery, repeated steroid injections, or long-term opioid use. CELZ-201 is engineered as an "off-the-shelf," allogenic cell therapy, offering scalability, consistency, and broad clinical applicability—key differentiators versus autologous approaches.
Creative Medical Technology's StemSpine® intellectual property portfolio, which covers both autologous and allogenic applications, further strengthens the Company's strategic position as it advances toward later-stage clinical development and potential commercialization.
What Comes Next
With enrollment complete, CELZ expects to:
- Continue scheduled DSMB reviews
- Advance toward topline safety and efficacy readouts
- Evaluate strategic pathways for late-stage development and commercialization including opioid patients.
Management believes these upcoming milestones represent multiple potential value-creation catalysts for shareholders as CELZ continues executing against its clinical and corporate roadmap.
"We are entering a results-driven phase for the Company," Warbington concluded. "Our focus is clear: execute flawlessly, generate compelling data, and unlock the full value of CELZ-201 for patients and shareholders alike."
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. With a diversified pipeline spanning orthopedics, immunotherapy, endocrinology, urology, and gynecology, the Company is committed to translating cutting-edge science into transformative, accessible therapies for patients with high unmet medical needs.
For more information, please visit www.creativemedicaltechnology.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding regulatory pathways, clinical development milestones, potential therapeutic applications, and the Company's strategic outlook. These statements are based on current expectations and are subject to various risks and uncertainties that could cause actual outcomes to differ materially. These risks include, but are not limited to, clinical trial results, regulatory decisions, manufacturing challenges, market conditions, and other factors described in the Company's filings with the SEC. Creative Medical Technology assumes no obligation to update such statements except as required by law.
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