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RESEARCH & EVIDENCE

Published proof. Not just promises.

Peer-reviewed clinical results, regulatory milestones, and the data behind StemCyte's therapeutic pipeline.

2 Peer-Reviewed Publications
3 Registered Trials
2 FDA Designations
1 BLA Approval
EMERGING

Investigational clinical programs

Emerging

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.

Primary Endpoint: Fatigue Resolution
Treatment
85%
Placebo
20%
p < 0.01 · EClinicalMedicine (The Lancet), 2026

NCT05682560 · StemCyte-sponsored · Completed

View trial details
Emerging

Acute 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.

Program Status
Phase II Active FDA + TFDA Approved

Published in Cell Transplantation and Tzu Chi Medical Journal, 2025. NCT02433509.

StemCyte-sponsored · Phase II active

Stroke trial details
LANDMARK

The publication that changed the path toward an HIV cure

Landmark

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.

Trial: IMPAACT P1107
Identifier: NCT02140944
StemCyte Role: Cord blood unit provider
Read the full story
2022
Presented at CROI
First public presentation of remission data.
2023
Published in Cell
Full case report confirming sustained remission.
Ongoing
IMPAACT P1107 continues
Long-term follow-up ongoing.
People living with HIV worldwide
38 million
Only three have ever been cured. The third used a StemCyte cord blood unit.
CLINICAL TRIAL REGISTRY

ClinicalTrials.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
REGULATORY

FDA Regulatory History

2026
Expanded Access Program

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.

2024
RMAT Designation: Long COVID

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.

2024
BLA Approval: REGENECYTE® (HPC, Cord Blood)

FDA biologics license approval for REGENECYTE® (HPC, Cord Blood), BLA 125764/0. FDA-licensed allogeneic hematopoietic progenitor cell therapy for use in patients with disorders affecting the hematopoietic system.

SUPPORTING EVIDENCE

Selected References in Cord Blood Science

1
Ballen KK, Gluckman E, Broxmeyer HE. "Umbilical cord blood transplantation: the first 25 years and beyond."
Blood. 2013.
Foundational review of cord blood transplantation outcomes over 25 years.
2
Cairo MS, Wagner JE, Fraser J, et al. "Indications for Hematopoietic Cell Transplantation with Cord Blood."
Biol Blood Marrow Transplant. 2019.
Established indications framework for cord blood transplantation.
3
Laskowitz DT, Bennett ER, Durham RJ, et al. "Allogeneic Umbilical Cord Blood Infusion for Adults With Ischemic Stroke."
Stem Cells Transl Med. 2018.
Phase I stroke trial evidence supporting cord blood in acute ischemic stroke.
4
Sun JM, Song AW, Case LE, et al. "Effect of Autologous Cord Blood Infusion on Motor Function in Cerebral Palsy."
Stem Cells Transl Med. 2017.
Randomized clinical trial of cord blood in cerebral palsy.
5
Escolar ML, Poe MD, Provenzale JM, et al. "Transplantation of Umbilical-Cord Blood in Babies with Infantile Krabbe's Disease."
N Engl J Med. 2005.
Landmark cord blood transplant study for metabolic/neurological disease.
6
Prasad VK, Kurtzberg J. "Cord Blood Transplantation for Metabolic Disorders."
Br J Haematol. 2010.
Evidence base for cord blood transplantation in metabolic disease.

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