CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 46 enrolled
Drug / intervention
Allo-MSCs +1 morebiological
Likely dose
Allo-MSCs 0.4mlfrom 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/NCT02509156
NCT02509156Phase 1Completed
CompareCT.gov

A Phase I, First-in-Human, Multicenter, Randomized, Double-Blinded, Placebo-Controlled Study of the Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Cancer Survivors With Anthracycline-Induced Cardiomyopathy

The University of Texas Health Science Center, Houston·interventional·Posted Jul 27, 2015·Updated Nov 5, 2020

In Brief

A Phase 1 clinical trial evaluating Allo-MSCs and Placebo for Cardiomyopathy Due to Anthracyclines. Completed, enrolled 46 participants across 7 sites.

Detailed Summary

The primary purpose of this study is to examine the safety and feasibility of delivering allogeneic human mesenchymal stem cells (allo-MSCs) by transendocardial injection to cancer survivors with left ventricular (LV) dysfunction secondary to anthracycline-induced cardiomyopathy (AIC). The secondary purpose of this study is to obtain preliminary evidence for therapeutic efficacy of allo-MSCs delivered by transendocardial injection to cancer survivors with LV dysfunction secondary to AIC.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCardiomyopathy Due to Anthracyclines
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 1CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 27, 2015
Enrollment StartAug 1, 2016
Primary CompletionNov 1, 2019
Study CompletionApr 20, 2020
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.9 years ago

Interventions

Allo-MSCsbiological

20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Placebobiological

20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)