Cell, 186(6), 1115–1126.e8. DOI: 10.1016/j.cell.2023.02.030
First documented possible HIV cure in a woman following a haplo-cord blood transplant. StemCyte-screened cord blood unit (CCR5-delta32 homozygous) contributed to the case.
PubMed →Published in eClinicalMedicine. NCT05682560.
Phase IIa randomized placebo-controlled trial demonstrating statistically significant reduction in CFQ-11 fatigue scores in the REGENECYTE® arm versus placebo, sustained through 26-week follow-up. By week 26, 85% of REGENECYTE recipients achieved complete fatigue resolution on CFQ-11, compared with 20% in the placebo group. Significance held at every timepoint (week 6, 12, 18 p<0.001; week 26 p=0.004).
PubMed Central →International Maternal Pediatric Adolescent AIDS Clinical Trials Network. NCT02140944.
Observational study of pediatric HIV-1 transplant recipients. StemCyte listed as collaborating organization. The NY Patient case (Hsu et al., 2023) was performed under this protocol.
ClinicalTrials.gov →Hsu et al., 29th Conference on Retroviruses and Opportunistic Infections, Feb 15, 2022, Denver.
First public presentation of The NY Patient case at CROI 2022 (Denver, Feb 15, 2022). The case was published in Cell the following year.
CROI →Nov 20, 2024
Approved under US License 2280 as the first commercial HPC, Cord Blood biologics license issued to a private cord blood bank in the United States.
FDA package insert (PDF) →Oct 3, 2024
Designation granted for REGENECYTE® in Long COVID indication, expediting development and review.
PR Newswire →Jan 26, 2026
Compassionate-use program for REGENECYTE® in Long COVID, allowing access while clinical development continues.
PR Newswire →2024 contract renewal
Statewide collection partner since 2013, recontracted in 2024. 83% of transplant units released through this program since 2013.
PR Newswire →Historical participation
StemCyte historically participated in the U.S. Health Resources and Services Administration NCBI program, contributing clinical-grade cord blood units.
Plasma-depletion processing technique for cord blood. Foundation for StemCyte's MaxCell® method.
Plasma-depletion processing technique.
Treatment of brain damage using umbilical cord blood cells.