Company Description
Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) is a clinical-stage biotechnology company focused on regenerative medicine, regenerative immunotherapy, and induced pluripotent stem cell (iPSC) technology. According to company disclosures and recent news, Creative Medical develops next‑generation regenerative and immune cell therapies that integrate cellular regeneration with AI-enabled analytics, targeting large unmet medical needs across autoimmune, inflammatory, neurological, metabolic, and biodefense-related conditions.
Core Focus in Regenerative Medicine and Immunotherapy
The company describes itself as a biotechnology holding company centered on regenerative medicine, with roots in stem cell research and the creation and licensing of intellectual property. Earlier descriptions highlight work with amniotic fluid–derived stem cells and applications intended to address male and female sexual dysfunction, infertility, miscarriages, and related issues. More recent communications emphasize a broader platform strategy in regenerative medicine and regenerative immunotherapy, supported by an expanding intellectual property portfolio.
Creative Medical positions its business around three principal cellular technology platforms:
- AlloStem® / CELZ‑201 (olastrocel) – an allogeneic, off‑the‑shelf perinatal tissue–derived cell therapy platform. The company reports that AlloStem has been cleared by the U.S. Food and Drug Administration (FDA) for clinical evaluation and is being developed under the product designation CELZ‑201, with the active cellular substance named olastrocel by the World Health Organization as an International Non‑Proprietary Name (INN).
- ImmCelz™ – a personalized regenerative immunotherapy platform that uses a patient’s own immune cells, which are extracted, cultured outside the body with proprietary cell‑free factors, and then re‑injected. The company states that this process is intended to "reprogram" or "supercharge" immune cells, endowing them with regenerative properties in addition to their innate functions, with applications in conditions such as Type 1 diabetes, heart failure, and other high‑burden diseases.
- iPScelz™ – an induced pluripotent stem cell (iPSC) platform derived from the AlloStem foundation. Creative Medical describes iPScelz as a next‑generation, renewable source for creating replacement cell types across a spectrum of degenerative diseases and as a core component of its AI‑enabled regenerative and biodefense initiatives.
Lead Clinical Programs and Therapeutic Areas
Creative Medical reports multiple FDA‑cleared clinical programs built on its AlloStem/olastrocel platform:
- CELZ‑201‑DDT (ADAPT Trial) for Degenerative Disc Disease and Chronic Lower Back Pain – The ADAPT trial is described as a randomized, double‑blind, placebo‑controlled, dose‑escalation Phase I/II study evaluating CELZ‑201 (olastrocel) delivered via a minimally invasive, ultrasound‑guided intramuscular procedure for chronic lower back pain associated with degenerative disc disease. The company states that the trial has FDA clearance and has received Fast Track designation for degenerative disc disease. Enrollment completion has been announced, and interim 180‑day data from the ADAPT trial show statistically significant and clinically meaningful improvements in functional disability (ODI%) and pain scores, with a favorable safety profile and no serious treatment‑related adverse events reported in an independent Data Safety Monitoring Board (DSMB) review.
- CELZ‑201 (CREATE‑1 Trial) for New‑Onset Type 1 Diabetes – Creative Medical describes the CREATE‑1 study as a clinical program focused on new‑onset Type 1 diabetes. The company characterizes this approach as targeting the autoimmune root cause of the disease rather than symptom management, and notes that the program leverages the same AlloStem/olastrocel foundation as its degenerative disc disease program.
In addition to these trials, the company has highlighted development of olastrocel for biodefense‑related indications and has referenced therapeutic exploration in autoimmune and immune‑mediated conditions. It emphasizes that the same underlying cellular platforms are being applied across multiple therapeutic areas to support scalability and cost efficiency.
Regenerative BioDefense and Veteran Health Initiatives
Through its wholly owned subsidiary BioDefense Inc., Creative Medical is advancing an AI‑enabled regenerative biodefense strategy. The company has announced a Burn Pit Initiative focused on U.S. military veterans exposed to toxic burn pits. Regulatory approval has been received for this initiative, enabling BioDefense Inc. to proceed with a program designed to build a large molecular and cellular database related to burn pit–associated toxic exposure.
According to company news, the Burn Pit Program aims to:
- Collect and analyze genomic and proteomic data from veterans affected by burn pit exposure.
- Use AI‑driven molecular modeling and machine learning to characterize disease pathways.
- Develop regenerative countermeasures using the company’s iPSC platform and analytical technologies.
The company indicates that this initiative will be executed using existing strategic partnerships, infrastructure, and vendor relationships, and has specifically noted a long‑standing collaboration with Greenstone Biosciences, Inc. as an AI and iPSC development partner. Creative Medical states that the program is intended to support future deployment of regenerative biodefense capabilities across both military and civilian populations.
AI Integration and Data‑Driven Development
Creative Medical describes the integration of artificial intelligence as a central element of its iPScelz and biodefense platforms. Company communications state that proprietary AI models are being designed to:
- Accelerate target discovery and optimize donor cell selection.
- Simulate in vivo behavior of cellular therapies before clinical testing.
- Decode genomic and proteomic signatures of toxic exposure.
- Model disease progression pathways and support precision regenerative strategies.
This AI‑enabled approach is presented as a way to improve the precision and efficiency of regenerative medicine research, reduce development time and cost, and support personalized treatment concepts based on patient‑specific cellular responses.
Intellectual Property and Platform Strategy
Creative Medical reports that its technology is protected by an intellectual property portfolio that includes numerous issued patents and pending applications. Recent disclosures highlight:
- A Notice of Allowance from the U.S. Patent and Trademark Office for a patent titled "Prevention and/or Treatment of Type 1 Diabetes by Augmentation of Myeloid Suppressor Cell Activity," covering an ImmCelz‑based, cell‑based immunotherapy approach to Type 1 diabetes, validated using cells from patients with the disease.
- U.S. patents related to ImmCelz programs in Type 1 diabetes and heart failure/post‑infarct pathological remodeling, which the company associates with supercharged regulatory T cell biology.
The company describes its overall strategy as a platform‑based model rather than a single‑asset approach. AlloStem, ImmCelz, and iPScelz are presented as interrelated platforms capable of generating multiple clinical programs, potential licensing opportunities, and collaborations. Creative Medical emphasizes that these platforms are intended to provide multiple opportunities across large therapeutic frontiers while seeking to manage development risk.
Capital Markets Activity and Corporate Governance
Creative Medical Technology Holdings, Inc. is incorporated in Nevada and trades on the Nasdaq under the symbol CELZ. The company has filed proxy statements and current reports with the U.S. Securities and Exchange Commission (SEC) describing its governance and financing activities.
Recent SEC filings detail, among other matters:
- A warrant exercise inducement transaction in which holders of existing warrants exercised those warrants for cash, with the company agreeing to issue new inducement warrants and to adjust certain existing warrant terms. The company has stated that net proceeds are intended for working capital and general corporate purposes.
- A definitive proxy statement for a special meeting of stockholders to approve the exercise in full of inducement warrants issued in October 2025, in order to comply with Nasdaq Listing Rule 5635(d).
- A definitive proxy statement for the company’s annual meeting of stockholders, covering the election of directors, an advisory vote on executive compensation, and ratification of the independent registered public accounting firm.
These filings provide insight into the company’s capital structure, stockholder voting matters, and approach to financing its clinical and platform development activities.
Business Model and Sector Classification
Based on available information, Creative Medical operates as a clinical‑stage biotechnology company within the broader category of research and development in biotechnology, which is part of the professional, scientific, and technical services sector. The company’s business model centers on:
- Developing cell‑based therapeutic candidates in regenerative medicine and regenerative immunotherapy.
- Advancing clinical programs such as CELZ‑201‑DDT for degenerative disc disease and CELZ‑201 for Type 1 diabetes.
- Building and protecting intellectual property around AlloStem, ImmCelz, iPScelz, and related applications.
- Applying AI‑enabled analytics to cellular and molecular data to support discovery, development, and biodefense initiatives.
Earlier descriptions also note that the company was formed to create and license intellectual property in the area of amniotic fluid–derived stem cells for therapeutic applications, including potential treatments for sexual dysfunction, infertility, miscarriages, and related conditions. More recent communications focus on chronic lower back pain, degenerative disc disease, Type 1 diabetes, cardiometabolic disease, and biodefense‑related exposures.
How Investors and Observers Use CELZ Information
Investors and analysts who follow CELZ often review:
- Clinical progress and data readouts from the ADAPT and CREATE‑1 trials and other programs involving olastrocel and ImmCelz.
- Regulatory designations and interactions, such as FDA Fast Track status for CELZ‑201‑DDT and WHO INN approval for olastrocel.
- Updates on the BioDefense Inc. Burn Pit Initiative and broader regenerative biodefense strategy.
- SEC filings related to capital raises, warrant transactions, and corporate governance matters.
Because Creative Medical remains in the clinical stage, outcomes from ongoing and future studies, along with regulatory decisions and financing activities, are key elements in understanding the company’s trajectory within the biotechnology sector.