A Phase 2 interventional study of myoblast and sham in Ischemic Cardiomyopathy, sponsored by Mytogen, Inc.. Status unknown at 1 site in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-02-29.
Sponsored by Mytogen, Inc. · Phase 2, Interventional, and Treatment
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.
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.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's planned enrollment of 165 is above the median of 51 across 609 interventional studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →This is the only study on the registry with Mytogen, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
myoblast
Biological: myoblast
sham injection procedure
Biological: sham
autologous myoblast
sham injection procedure
Kansas City Cardiomyopathy Questionnaire
Time frame: 6 months
Cardiovascular mortality
Time frame: 12 months
This study is status unknown, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.
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