RegeneCyte / StemCyte - LARVOL DELTA

Innovative Treatment for Post-COVID Syndrome: A Clinical Breakthrough (ASH 2024) - "The clinical evidence of profound fatigue reduction and a high safety profile underscores its therapeutic promise. RegeneCyte® infusion presents a viable treatment option for post-COVID syndrome, addressing unmet medical needs and expanding the scope of RegeneCyte® applications."

Clinical • CNS Disorders • Fatigue • Hematological Malignancies • Infectious Disease • Novel Coronavirus Disease • Oncology • CD34

A Study of Human Umbilical Cord Blood (REGENECYTE) Infusion in Patients With Post-COVID Condition (clinicaltrials.gov) - P3 | N=60 | Not yet recruiting | Sponsor: StemCyte, Inc.

New P3 trial • Fatigue • Infectious Disease • Novel Coronavirus Disease

Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients with Post-COVID Syndrome (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: StemCyte, Inc. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

U.S. FDA Approves StemCyte Biologics License Application for REGENECYTE Cord Blood Cell Therapy Product (PRNewswire) - "StemCyte Inc., a wholly owned subsidiary of StemCyte International Ltd., announced today that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for its HPC, Cord Blood product REGENECYTE, a vital cord blood stem cell therapy for transplantation in patients with blood and immune system disorders. With this approval, StemCyte became the 15th company to receive BLA approval in 2024 and the first commercial U.S. based biotech company to secure a biologics license for cord blood stem cell therapy."

FDA approval • Hematological Disorders • Immunology

Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients With Post-COVID Syndrome (clinicaltrials.gov) - P2 | N=30 | Active, not recruiting | Sponsor: StemCyte, Inc. | Recruiting ➔ Active, not recruiting | Phase classification: P2a ➔ P2 | Trial completion date: Oct 2024 ➔ Feb 2025

Enrollment closed • Phase classification • Trial completion date • Infectious Disease • Novel Coronavirus Disease

Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients With Post-COVID Syndrome (clinicaltrials.gov) - P2a | N=30 | Recruiting | Sponsor: StemCyte, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Novel Coronavirus Disease

Human Umbilical Cord Blood (RegeneCyte) Infusion in Patients With Post-COVID Syndrome (clinicaltrials.gov) - P2a | N=30 | Not yet recruiting | Sponsor: StemCyte, Inc.

New P2a trial • Infectious Disease • Novel Coronavirus Disease