Multi-intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Heart Failure With Reduced Ejection Fraction（PRIME-HFrEF Study）

Phase 1/2 Completed 40 enrolled Shanghai East Hospital

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study is an exploratory clinical study to observe the safety and efficacy of the Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in the heart failure patients with reduced ejection fraction. The study was a 12 months single center, randomized, double-blind, placebo-controlled trial that included 12 weeks of treatment, and 9 months of follow-up.

Timeline

Start: 2021-07-28
Primary completion: 2023-01-17
Completion: 2023-04-04

Outcome

Missed primary endpoint

paper no significant difference in ΔLVEF was observed between groups. PMID 41888108 ↗

paper The incidence of SAEs did not differ significantly between treatment groups. PMID 41888108 ↗

Publications

Han W, Jiao Y, Chen W, Gong X, Hu H, Xin Y, Guan S, Zhao J, Zhang Q, Yang B, Pan J, Wang H, Lu Q, Chu S, Cai D, Zheng L, Jia W, He Z, Yang H, Sun YE, Liu Z. PRIME-HFrEF Trial: a randomized, double-blind, multi-dose umbilical cord-derived mesenchymal stem cell regimen for heart failure. Signal Transduct Target Ther. 2026 Mar 26;11(1):112. doi: 10.1038/s41392-026-02678-5.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	human umbilical cord mesenchymal stem cells	Cell therapy	1e+06 cells/kg	Intravenous