Creative Medical Technology Holdings, Inc. Completes Enrollment in FDA-Cleared ADAPT Trial for CELZ-201-Olastrocel, Marking Major Clinical Inflection Point

Rhea-AI Summary

Creative Medical Technology (NASDAQ: CELZ) announced on Dec 17, 2025 that it has completed patient enrollment in the FDA-cleared ADAPT clinical trial evaluating CELZ-201 (Olastrocel) for chronic lower back pain associated with degenerative disc disease. A prior independent DSMB safety review confirmed a favorable safety profile with no significant adverse events. With enrollment finished, the program moves to follow-up and data analysis as the company advances toward topline safety and efficacy readouts and late-stage development planning.

Positive

• Enrollment completed in ADAPT trial on Dec 17, 2025
• Independent DSMB confirmed favorable safety profile, no significant adverse events
• FDA-cleared ADAPT randomized, double-blind, placebo-controlled design
• CELZ-201 is an off-the-shelf, allogenic perinatal tissue-derived cell therapy
• Company plans topline safety and efficacy readouts and commercialization planning

Negative

• None.

Key Figures

Chronic back pain patients more than 16 million Americans U.S. population impacted by chronic lower back pain

Market Reality Check

$2.12 Last Close

Volume Volume 31,500 vs 20-day average 92,636, indicating muted trading ahead of the news. low

Technical Shares at $2.09 are below the 200-day MA of $2.84 and sit 69.71% under the 52-week high.

Peers on Argus

CELZ fell 1.42% pre-news while peers were mixed: ERNA up 0.77%, APRE down 2.05%, INAB down 3.23%, NLSP down 1.05%, RNAZ down 1.11%. Moves do not indicate a unified sector trend.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 02	Naming/IP milestone	Positive	-11.8%	WHO granted INN ‘olastrocel’ for CELZ-201, supporting global development.
Oct 30	Strategic initiative	Positive	-13.0%	Launched BioDefense initiative for veterans using iPSC platform and AI.
Oct 29	Warrant financing	Negative	-32.7%	Induced warrant exercises for $4.2M gross proceeds with new warrants issued.
Oct 27	Shareholder update	Positive	+5.4%	Outlined CELZ-201 Fast Track ADAPT trial and 2026 data milestones.
Oct 07	Patent news	Positive	+0.9%	Announced two U.S. patents for ImmCelz regulatory T cell platform.

Pattern Detected

Recent news shows mixed reactions: several positive milestones drew negative price moves, while others aligned, suggesting inconsistent trading response to catalysts.

Recent Company History

Over the last few months, CELZ has combined clinical, IP, and financing milestones. On Oct 7, it highlighted new ImmCelz™ patents and large heart-failure and angina target populations. A Oct 27 shareholder letter detailed FDA‑cleared CELZ‑201 programs, Fast Track status, and extensive AlloStem manufacturing. Subsequent warrant inducement and resale structures on Oct 29–31 added dilution risk. In Dec, WHO granted the INN “olastrocel” to CELZ‑201. Today’s completion of ADAPT trial enrollment fits this ongoing push toward later-stage development.

Regulatory & Risk Context

Active S-3 Shelf Registration 2025-11-21

An effective Form S-3 dated Nov 21, 2025 registers 2,790,340 shares for resale upon exercise of inducement warrants from the October 29, 2025 transaction. These secondary sales would not raise new capital directly but could add selling pressure if large blocks are sold after warrant exercise.

Market Pulse Summary

This announcement highlights completion of enrollment in the FDA‑cleared ADAPT trial for CELZ‑201, moving CELZ into a follow‑up and data‑analysis phase for chronic lower back pain affecting more than 16 million Americans. It builds on prior DSMB safety review support and positions the company for upcoming topline readouts. Investors may track clinical outcomes, regulatory interactions, and how existing warrant and resale structures influence the capital base as the program advances.

Key Terms

data safety monitoring board medical

"Enrollment completion follows a previously announced positive independent Data Safety Monitoring Board (DSMB) safety review..."

A data safety monitoring board is a group of experts who regularly review information from a research or testing process to ensure it is safe and ethical. Think of them as watchdogs that watch over ongoing projects to protect participants and ensure everything is proceeding correctly. Their oversight helps maintain trust and safety, which is important for investors who want to see responsible management and reliable results.

ctcae v5.0 medical

"including DSMB reviews and adverse event tracking aligned with CTCAE v5.0 standards."

A standardized checklist and grading system used in clinical trials to describe and score the severity of side effects from medical treatments, where higher grades mean more serious adverse events. Investors use it like a ruler for safety: trial results reported with these grades help predict regulatory decisions, potential delays, extra costs, and how easily a drug can reach and stay on the market, all of which affect a company’s financial outlook.

randomized, double-blind, placebo-controlled medical

"is a randomized, double-blind, placebo-controlled, dose-escalation study designed to evaluate..."

A "randomized, double-blind, placebo-controlled" process is a method used to test the effectiveness of a new treatment or intervention. Participants are randomly assigned to different groups, with one receiving the real treatment and the other a fake version, called a placebo. Neither the participants nor the researchers know who is receiving which, which helps ensure unbiased results. For investors, this rigorous approach increases confidence that the findings are accurate and not influenced by guesswork or bias.

allogenic cell therapy medical

"CELZ-201 is engineered as an “off-the-shelf,” allogenic cell therapy, offering scalability..."

Allogenic cell therapy uses living cells taken from a donor and given to another person to treat disease or repair tissue, similar to receiving a blood transfusion or organ transplant but with therapeutic cells. Investors watch these therapies because they can offer off‑the‑shelf products that scale more easily than patient‑specific treatments, yet they carry commercial risks tied to immune rejection, complex manufacturing, high regulatory hurdles, and uncertain long‑term safety and reimbursement.

intramuscular medical

"preliminary efficacy of CELZ-201 delivered via a minimally invasive, ultrasound-guided intramuscular procedure."

A way of giving a medicine or vaccine by injecting it deep into a muscle, typically using a syringe and needle so the drug is absorbed into the bloodstream more steadily than a skin shot but faster than swallowing a pill. Investors care because this delivery method affects how quickly and reliably a treatment works, the type of manufacturing and packaging needed, clinical trial design and regulatory requirements, and patient or provider preferences that influence market uptake.

AI-generated analysis. Not financial advice.

Completion of Enrollment Positions CELZ for Near-Term Data Catalysts and Accelerates Path Toward Commercialization of a Transformative, Non-Opioid Therapy for Chronic Lower Back Pain

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.

Contact

Creative Medical Technology Holdings, Inc.
IR@CreativeMedicalTechnology.com
www.creativemedicaltechnology.com

Investor Relations:
Devin Sullivan
The Equity Group Inc.
dsullivan@theequitygroup.com

Conor Rodriguez
The Equity Group Inc.
crodriguez@theequitygroup.com

RedChip Companies:
Dave Gentry — CELZ@redchip.com | 1-407-644-4256
Paul Kuntz — paul@redchip.com | 412-708-4590

FAQ

What did Creative Medical Technology (CELZ) announce on December 17, 2025?

CELZ completed patient enrollment in the FDA-cleared ADAPT trial testing CELZ-201 for chronic lower back pain.

What did the independent DSMB report say about CELZ-201 safety in the ADAPT trial?

The DSMB confirmed a favorable safety profile with no significant adverse events and supported continued trial advancement.

What is CELZ-201 (Olastrocel) being tested for in the ADAPT trial (CELZ-201-ADAPT-2023)?

CELZ-201 is a perinatal tissue-derived, allogenic cell therapy for chronic lower back pain associated with degenerative disc disease.

How is the ADAPT trial designed for CELZ-201 (CELZ symbol)?

ADAPT is a randomized, double-blind, placebo-controlled, dose-escalation study using a minimally invasive ultrasound-guided intramuscular procedure.

What are the next steps after enrollment completion for CELZ (NASDAQ: CELZ)?

The company will continue DSMB reviews, conduct follow-up and data analysis, and advance toward topline safety and efficacy readouts and late-stage planning.