A Prospective Randomized Controlled Study of Multi-intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells in Patients with Heart Failure and Reduced Ejection Fraction (PRIME-HFrEF) Trial: Rationale and Design

Overview

Journal Contemp Clin Trials Commun

Date 2024 Sep 9

PMID 39246626

Authors

Xin Gong

Yuheng Jiao

Hao Hu

Rongzhen Zhang

Wenwen Jia

Jun Zhao

Zhongmin Liu

Yuanfeng Xin

Wei Han

Affiliations

Soon will be listed here.

Abstract

Background And Objective: The use of mesenchymal stem cells for heart failure treatment has gained increasing interest. However, most studies have relied on a single injection approach, with no research yet confirming the effects of multiple administrations. The present trial aims to investigate the safety and efficacy of multi-intravenous infusion of umbilical cord-mesenchymal stem cells (UC-MSCs) in patients with heart failure and reduced ejection fraction (HFrEF).

Methods: The PRIME-HFrEF trial is a single-center, prospective, randomized, triple-blinded, placebo-controlled trial of multi-intravenous infusion of UC-MSCs in HFrEF patients. A total of 40 patients meeting the inclusion criteria for HFrEF were enrolled and randomized 1:1 to the MSC group or the placebo group. Patients enrolled will receive intravenous injections of either UC-MSCs or placebo every 6 weeks for three times. Both groups will be followed up for 12 months. The primary safety endpoint is the incidence of serious adverse events. The primary efficacy endpoint is a change in left ventricular ejection fraction (LVEF) measured by left ventricular opacification (LVO) with contrast echocardiography and magnetic resonance imaging (MRI) at 12 months. The secondary endpoints include a composite of the incidence of death and re-hospitalization caused by heart failure at the 12th month, serum NT-proBNP, growth stimulation expressed gene 2 (ST), and a change of right ventricular structure and function.

Conclusions: The PRIME-HFrEF study is designed to shed new light on multiple UC-MSC administration regimens for heart failure treatment.

Citing Articles

Umbilical cord-derived mesenchymal stromal cells: Promising therapy for heart failure.

Li Y, Chen E, Ren B World J Cardiol. 2025; 17(1):101153.

PMID: 39866217 PMC: 11755126. DOI: 10.4330/wjc.v17.i1.101153.

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