CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 125 enrolled
Drug / intervention
Mesenchymal Stem Cells (MSC) +2 morebiological
Likely dose
Mesenchymal Stem Cells (MSC) 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/NCT02501811
NCT02501811Phase 2Completed
CompareCT.gov

A Phase II, Randomized, Placebo-Controlled Study of the Safety, Feasibility, & Efficacy of Autologous Mesenchymal Stem Cells & C-kit+ Cardiac Stem Cells, Alone or in Combination, Administered Transendocardially in Subjects With Ischemic HF

The University of Texas Health Science Center, Houston·interventional·Posted Jul 17, 2015·Updated Apr 26, 2021

In Brief

A Phase 2 clinical trial evaluating Mesenchymal Stem Cells (MSC), c-kit+ cells, and 1 other intervention for Ischemic Cardiomyopathy. Completed, enrolled 125 participants across 7 sites.

Detailed Summary

This is a phase II, randomized, placebo-controlled clinical trial designed to assess feasibility, safety, and effect of autologous bone marrow-derived mesenchymal stem cells (MSCs) and c-kit+ cells both alone and in combination (Combo), compared to placebo (cell-free Plasmalyte-A medium) as well as each other, administered by transendocardial injection in subjects with ischemic cardiomyopathy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIschemic Cardiomyopathy
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 17, 2015
Enrollment StartOct 1, 2015
Primary CompletionJun 25, 2020
Study CompletionJul 22, 2020
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 11.0 years ago

Interventions

Mesenchymal Stem Cells (MSC)biological

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

c-kit+ cellsbiological

15 transendocardial injections of 0.4ml c-kit+ cells administered to the left ventricle via NOGA Myostar injection catheter (single procedure)

Placebo (Plasmalyte A)biological

15 transendocardial injections of 0.4ml placebo administered to the left ventricle via NOGA Myostar injection catheter (single procedure)