Creative Medical Technology Holdings Announces World Health Organization Approval of "olastrocel" as INN for Lead Allogeneic Cell Therapy CELZ-201
PHOENIX, Dec. 02, 2025 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ) ("Creative Medical" or the "Company"), a clinical-stage biotechnology company developing next-generation regenerative and immune cell therapies, today announced that the World Health Organization (WHO) has approved "olastrocel" as the International Non-Proprietary Name (INN) for the active cellular substance in CELZ-201, the Company's lead allogeneic cell therapy also known as AlloStem®.
The INN is the globally standardized, unique scientific name used by regulators, clinicians, researchers, and global markets to identify a therapeutic substance throughout its development and commercialization lifecycle. This assignment is a key global milestone that typically occurs as a program advances into later regulatory stages and requires unified international identification.
"Securing the name ‘olastrocel' marks an important advancement for our program," said Timothy Warbington, President and CEO of Creative Medical. "A WHO-recognized INN is foundational for global development, medical adoption, and long-term scalability. It provides a cohesive scientific identity for the asset as we continue to execute on our clinical strategy in large markets with significant unmet medical needs."
Mr. Warbington continued, "From an investor perspective, this milestone reflects disciplined progress and strengthens the foundation for the olastrocel platform. Combined with our FDA Fast Track designation in degenerative disc disease, we believe the program is well-positioned as we move toward additional clinical catalysts ahead. The therapeutic areas we are targeting - chronic lower back pain, diabetes, and immune-mediated conditions - represent multi-billion-dollar opportunities where innovation is urgently needed.
"Our team remains focused, data-driven, and committed to advancing olastrocel through the next phases of development," he added. "This is an exciting moment for Creative Medical and our shareholders as we continue building a differentiated, next-generation cell therapy franchise."
Why the INN Matters
The assignment of "olastrocel" provides:
- Globally harmonized scientific identification of the active substance
- Regulatory and clinical clarity across jurisdictions during development
- Improved efficiency in global submissions, labeling, and pharmacovigilance
- A competitive advantage as this therapy progresses toward later-stage development
- Strengthened positioning in sizable therapeutic markets
About Olastrocel (CELZ-201)
olastrocel is an allogeneic, off-the-shelf cellular therapeutic candidate derived from perinatal tissue and developed under the Company's AlloStem® platform. It is in clinical development for:
- Chronic lower back pain & degenerative disc disease (DDD)
- Type 1 diabetes (new-onset)
- Biodefense-related indications
About Creative Medical Technology Holdings, Inc.
Creative Medical Technology Holdings, Inc. is a clinical-stage biotechnology company advancing a pipeline of cell and immune therapies targeting unmet needs in neurology, urology, orthopedics, and autoimmune diseases. The Company leverages proprietary regenerative medicine platforms, extensive scientific expertise, and a robust regulatory strategy to accelerate therapeutic innovation. 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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