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

NCT04992832 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-12-07

No results posted yet for this study

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.

Conditions

  • Heart Failure, Systolic

Interventions

BIOLOGICAL

human umbilical cord mesenchymal stem cells

Human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group.

OTHER

human serum albumin

Saline solution containing 1 percent human serum albumin will be infused to the control group.

Sponsors & Collaborators

  • Shanghai East Hospital

    lead OTHER

Principal Investigators

  • Zhongmin Liu, Doctor · Shanghai East Hospital, Shanghai Tongji University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04992832 on ClinicalTrials.gov