CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
human umbilical cord mesenchymal stem cells +1 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04992832
NCT04992832Phase 2Completed
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Multi-intravenous Infusion of Umbilical Cord Mesenchymal Stem Cells for Treatment in Heart Failure Patients With Reduced Ejection Fraction: A Randomized, Double Blind, Placebo-Controlled, Prospective Clinical Study

Shanghai East Hospital·interventional·Posted Aug 5, 2021·Updated Dec 7, 2023

In Brief

A Phase 2 clinical trial evaluating human umbilical cord mesenchymal stem cells and human serum albumin for Heart Failure, Systolic. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure, Systolic
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedAug 5, 2021
Enrollment StartJul 28, 2021
Primary CompletionJan 17, 2023
Study CompletionApr 4, 2023
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 4.9 years ago

Interventions

human umbilical cord mesenchymal stem cellsbiological

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

human serum albuminother

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