StemCyte's clinical research pipeline includes three sponsored trials: REGENECYTE® Phase II for Long COVID (NCT05682560, RMAT-designated), Phase I for acute ischemic stroke (NCT02433509, published in Cell Transplantation 2021), and Phase II for cerebral palsy (NCT06377982). StemCyte also contributed cord blood to the first reported HIV cure achieved via cord blood transplantation, the New York Patient, published in Cell in 2023. StemCyte, Inc. was founded in 1997, is FACT and AABB accredited, and the U.S. licensee of REGENECYTE® under FDA US License 2280.
Published proof. Not just promises.
Peer-reviewed clinical results, regulatory milestones, and the data behind StemCyte's therapeutic pipeline.
Investigational clinical programs
Post-COVID syndrome: Phase IIa results
A randomized, double-blind, placebo-controlled trial evaluating REGENECYTE® in adults with persistent post-COVID fatigue demonstrated statistically significant improvement at the primary endpoint.
NCT05682560 · StemCyte-sponsored · Completed
View trial detailsAcute ischemic stroke recovery
Phase I completed and published. A patient with acute ischemic stroke hemiplegia regained complete motor function within 12 months of receiving a single IV infusion of allogeneic cord blood mononuclear cells.
Published in Cell Transplantation and Tzu Chi Medical Journal, 2025. NCT02433509.
StemCyte-sponsored · Phase II active
Stroke trial detailsThe publication that changed the path toward an HIV cure
HIV-1 remission following CCR5Δ32/Δ32 haplo-cord transplant in a woman living with HIV
Published in Cell, 2023 · Hsu et al.
A StemCyte-screened cord blood unit with a naturally occurring CCR5Δ32/Δ32 mutation contributed to the first possible HIV remission and potential cure in a woman. Known as the "New York Patient," she is only the third person in history to achieve remission and possible cure following transplant.
Read the full storyClinicalTrials.gov
| Trial | Identifier | Phase | Status | Indication | Sponsor Role |
|---|---|---|---|---|---|
| Post-COVID Syndrome | NCT05682560 | Phase IIa | Completed | Long COVID fatigue | Sponsor |
| Acute Ischemic Stroke | NCT02433509 | Phase II | Active | Acute ischemic stroke | Sponsor |
| Toward an HIV Cure (P1107) | NCT02140944 | Observational | Active | HIV after cord blood transplant | Collaborator |
FDA Regulatory History
FDA clearance for Expanded Access Program for REGENECYTE® in Long COVID. Provides access to REGENECYTE® for patients with serious post-COVID syndrome who are unable to participate in clinical trials.
Regenerative Medicine Advanced Therapy (RMAT) designation for REGENECYTE® in Long COVID. RMAT is one of the FDA's most expedited pathways, reserved for regenerative therapies that show early evidence of addressing serious conditions.
FDA biologics license approval for REGENECYTE® (HPC, Cord Blood), US License 2280. FDA-licensed allogeneic hematopoietic progenitor cell therapy for use in patients with disorders affecting the hematopoietic system.
Selected References in Cord Blood Science
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