Longeveron’s Stem Cell Therapy, Lomecel-B, Receives International Approval as Laromestrocel: A Major Milestone in Regenerative Medicine

Lomecel-B™: A Revolutionary Cellular Therapy with the New INN “Laromestrocel”

Lomecel-B™, a proprietary, scalable, allogeneic cellular therapy developed by Longeveron Inc., has recently been granted an International Non-proprietary Name (INN) of “laromestrocel” by the World Health Organization (WHO). This significant milestone marks an important step forward in the recognition and acceptance of Lomecel-B™ as a potential treatment for various life-threatening and chronic aging-related conditions.

About Lomecel-B™

Lomecel-B™ is a unique cellular therapy that is being evaluated in two distinct indications: Alzheimer’s disease and hypoplastic left heart syndrome (HLHS). HLHS is a rare pediatric disease, and Alzheimer’s disease is a chronic and progressive neurodegenerative disorder.

FDA Regenerative Medicine Advanced Therapy (RMAT) Designation

In February 2025, Longeveron Inc. announced that Lomecel-B™ was the first cellular therapeutic candidate to receive U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer’s disease. This designation is given to regenerative medicine therapies that have the potential to treat, modify, reverse, or cure serious or life-threatening conditions.

Impact on Individuals

For individuals diagnosed with Alzheimer’s disease or HLHS, the development of Lomecel-B™ and its recognition through the INN “laromestrocel” brings hope for potential new treatment options. While more research is needed to determine the efficacy and safety of Lomecel-B™ in these conditions, the designation as an RMAT and the granting of an INN are important steps towards bringing this therapy to the market.

Global Implications

The approval of an INN for Lomecel-B™ by the WHO has global implications, as it allows for a standardized nomenclature for the therapy. This can lead to improved communication and collaboration among researchers, healthcare professionals, and regulatory agencies in the development and implementation of this therapy.

Conclusion

The granting of an INN “laromestrocel” to Lomecel-B™ by the World Health Organization marks an important milestone in the recognition and acceptance of this cellular therapy as a potential treatment for life-threatening and chronic aging-related conditions. This designation, along with the U.S. FDA RMAT designation for Alzheimer’s disease, brings hope for individuals diagnosed with these conditions and contributes to the global effort to advance the field of regenerative medicine.

  • Lomecel-B™ is a proprietary, scalable, allogeneic cellular therapy developed by Longeveron Inc.
  • It has been granted an INN “laromestrocel” by the World Health Organization.
  • Lomecel-B™ is being evaluated for Alzheimer’s disease and hypoplastic left heart syndrome (HLHS).
  • It is the first cellular therapeutic candidate to receive U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer’s disease.
  • The approval of an INN for Lomecel-B™ has global implications, allowing for standardized nomenclature and improved communication and collaboration.

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