Study to Examine the Safety and Effectiveness of Implanted Skeletal Muscle Cells (Cells Removed From the Thigh Muscle) Into Scarred Areas of Heart Muscle After Heart Attack.
This study has been terminated.
Information provided by:
First received: January 21, 2005
Last updated: August 3, 2009
Last verified: November 2006
Study to examine the safety and effectiveness of implanted skeletal muscle cells (cells removed from the thigh muscle) into scarred areas of heart muscle after heart attack.
Ischemic Heart Failure
Ischemic Heart Disease
Drug: Cellular Therapy (Cultured Autologous Skeletal Myoblast Transplantation)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Evaluation of Skeletal Myoblast Transplant for Treating Ischemic Heart Failure|
Resource links provided by NLM:
MedlinePlus related topics: Cardiomyopathy Coronary Artery Disease Heart Attack Heart Diseases Heart Failure ScarsU.S. FDA Resources
Further study details as provided by Genzyme:
Primary Outcome Measures:
- Recovery of contractility within previously akinetic areas of the heart (areas without motion/contraction) that have received treatment (cells from the patient's thigh muscle or placebo), and change in left ventricular EF as assessed by echocardiography
Secondary Outcome Measures:
- Time-to-first major adverse cardiac event (cardiovascular related death, non-cardiovascular death, congestive heart failure, resuscitated sudden death, myocardial infarction (heart attack) and stroke.
|Study Start Date:||November 2002|
|Estimated Study Completion Date:||March 2008|
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00102128
|Clermont Ferrand, France|
|Bad Oeynhausen, Germany|
|Cambridge, United Kingdom|
|London, United Kingdom|
|Southampton, United Kingdom|
Sponsors and Collaborators
|Study Director:||Medical Monitor||Genzyme|