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The Transendocardial Autologous Cells (hMSC) or (hMSC) and (hCSC) in Ischemic Heart Failure Trial. — TAC-HFT-II  

Myocardial Infarction Clinical Trial

Official title:
A Phase I/II, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Transendocardial Injection of Autologous Human Cells (Mesenchymal or the Combination of MSC and Cardiac Stem Cells) in Patients With Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction.

Clinical Trial Summary

Before initiating the full randomized study, a Pilot Safety Phase will be performed. In this phase the composition of cells administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested. The randomized portion of the study will be conducted after a full review of the safety data from the pilot Phase by the Data safety monitoring board. Following the Pilot Phase of five (5) Fifty (50) patients scheduled to undergo cardiac catheterization and meeting all inclusion/exclusion criteria will be evaluated at baseline. Patients will be randomized in a 2:2:1 ratio to one of three Treatment Strategies.

Clinical Trial Description

A Phase I/II, Randomized, Placebo-Controlled Study of the Safety and Efficacy of Transendocardial Injection of Autologous Human Cells (Mesenchymal or the combination of MSC and Cardiac Stem Cells) in Patients With Chronic Ischemic Left Ventricular Dysfunction and Heart Failure Secondary to Myocardial Infarction. A total of 55 subjects participating, with 5 in the pilot phase and 50 in the randomized phase. Patients with chronic ischemic left ventricular dysfunction and heart failure secondary to MI scheduled to undergo cardiac catheterization. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02503280
Study type Interventional
Source University of Miami
Contact
Status Withdrawn
Phase Phase 1/Phase 2
Start date March 1, 2025
Completion date March 2032
View Details
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