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StemCyte Biologics is the clinical development arm of StemCyte, Inc., advancing cord blood-derived cell therapies for serious diseases. The pipeline includes REGENECYTE® (FDA-licensed under US License 2280 for unrelated allogeneic hematopoietic progenitor cell transplantation) and three StemCyte-sponsored clinical trials covering Long COVID (NCT05682560), acute ischemic stroke (NCT02433509), and cerebral palsy (NCT06377982). REGENECYTE® holds FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Long COVID.

Regenerative Therapeutics

Advancing cell therapy from bench to bedside

REGENECYTE® is FDA-licensed under US License 2280. An active clinical pipeline. 27 years of stem cell science translated into patient outcomes.

FDA
FDA Biologics License
US License 2280 · Approved 2024
2,300+ transplants
Across 325+ institutions
Biologics Programs
Cord blood-derived · Research & manufacturing
GMP
FDA-licensed facility
Available
HPC, Cord Blood · Phase IIa · NCT05682560
85%
fatigue resolution vs 20% placebo
Completed · Published
HPC, Cord Blood · Phase II
Phase II
FDA-authorized (IND)
Active
FDA US License 2280 RMAT Designation FACT Accredited AABB Accredited 325+ Institutions

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