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Study to Assess the Efficacy and Safety of Transplanting Autologous Skeletal Myoblasts, Into Infarcted Heart, Using an Catheter Delivery System — CAuSMIc II  

Ischemic Cardiomyopathy Clinical Trial

Official title:
A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Trial to Assess the Efficacy, Safety and Tolerability of Transplanting Autologous Skeletal Myoblasts, Into Infarcted Myocardium, Using an Endomyocardial Delivery System

Clinical Trial Summary

The purpose of this study is to evaluate the safety and effectiveness of injecting myoblasts (grown from your own skeletal muscle), using a catheter device, directly into the damaged heart muscle for treatment of severe heart failure.

Clinical Trial Description

Given the limited treatment options available to patients with congestive heart failure, there is a need for alternative therapies. Autologous skeletal myoblast transplantation has been demonstrated in pre-clinical studies to be a safe and effective treatment of heart failure. Initial clinical studies have shown that autologous myoblasts can be delivered into infracted myocardium by both direct epicardial and endomyocardial injection. However, autologous skeletal myoblast transplantation via percutaneous endomyocardial injection has the potential to play a significant role in such congestive heart failure patients without the need for surgical risk and general anesthesia. Thus, a Phase 2 clinical trial is proposed in order to evaluate the effectiveness of autologous myoblast delivered by endomyocardial injection for the treatment congestive heart failure. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00626314
Study type Interventional
Source Mytogen, Inc.
Contact JEROMY BROWN
Phone 617-423-7999
Email JBrown@ccstrials.com
Status Not yet recruiting
Phase Phase 2
Start date March 2008
Completion date August 2010
View Details
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