Creative Medical Technology Holdings Announces World Health Organization Approval of “olastrocel” as INN for Lead Allogeneic Cell Therapy CELZ-201

Rhea-AI Summary

Creative Medical (NASDAQ: CELZ) announced on Dec 2, 2025 that the World Health Organization approved olastrocel as the International Non‑Proprietary Name (INN) for the active cellular substance in its lead allogeneic cell therapy CELZ‑201 (AlloStem).

The INN gives a globally standardized scientific name to the asset, aiding regulatory and clinical clarity, pharmacovigilance, labeling, and international development. Company leadership said the milestone supports global advancement and complements the program’s FDA Fast Track designation in degenerative disc disease. Olastrocel is being developed as an off‑the‑shelf perinatal‑tissue cell therapy for chronic lower back pain/DDD, new‑onset type 1 diabetes, and biodefense‑related indications.

Insights

Regulatory strategist

WHO approval of the INN olastrocel standardizes global identification and modestly advances regulatory positioning for CELZ-201.

The WHO assignment of the International Non‑Proprietary Name olastrocel gives the active substance in CELZ-201 a single, globally recognized scientific name, which reduces ambiguity in regulatory filings, labeling, and pharmacovigilance across jurisdictions. The release notes this milestone typically aligns with programs moving into later regulatory stages and frames the INN as supportive of global development and medical adoption.

Dependencies and risks include remaining clinical and regulatory steps before commercial approval; the statement references an existing FDA Fast Track designation for degenerative disc disease but provides no clinical outcomes or timelines. The practical benefit is administrative and preparatory rather than efficacy‑related; it eases multinational coordination but does not alter clinical or safety data requirements.

Watch for upcoming clinical catalysts and formal regulatory filings referenced as "additional clinical catalysts ahead," noting no dates were given; monitor trial readouts, pivotal study starts, and any filings tied to these next steps for the clearest near‑term impact.

Global assignment of this unique name enhances international clarity, strengthens regulatory positioning, and supports olastrocel’s advancement across large unmet-need global markets

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.

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 (CELZ) announce on December 2, 2025 about olastrocel?

The company announced WHO approval of olastrocel as the International Non‑Proprietary Name for CELZ‑201.

How does the WHO INN approval of olastrocel affect CELZ‑201 regulatory processes?

The INN provides globally harmonized identification, aiding submissions, labeling, and pharmacovigilance across jurisdictions.

Which indications is olastrocel (CELZ‑201) being developed for?

Olastrocel is in clinical development for chronic lower back pain/degenerative disc disease, new‑onset type 1 diabetes, and biodefense‑related indications.

Does Creative Medical have any FDA designation for olastrocel (CELZ‑201)?

Yes; the company cites an existing FDA Fast Track designation in degenerative disc disease.

Why is an INN like olastrocel important for investors in CELZ?

An INN can improve regulatory and commercial clarity internationally and is a milestone that typically aligns with later clinical development stages.

What is the origin and format of olastrocel (CELZ‑201)?

Olastrocel is described as an allogeneic, off‑the‑shelf cellular therapeutic derived from perinatal tissue under the AlloStem platform.