drugset / Trial / NCT04992832

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

NCT04992832

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

Drugs

EvaluationDrugModalityDoseRoute
Subject human umbilical cord mesenchymal stem cells Cell therapy 1e+06 cells/kg Intravenous