Treatment of Myocardial Infarction With Autologous Bone Marrow Derived Stem Cells
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute Myocardial Infarction
- Sponsor
- Odense University Hospital
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Safety
- Last Updated
- 15 years ago
Overview
Brief Summary
The aim of the study is to investigate whether infusion of autologous bone marrow derived stem cells can improve cardiac function in the aftermath of a myocardial infarction.
Detailed Description
Primary coronary intervention within a few hours of a myocardial infarction has greatly reduced mortality as well as the risk of developing chronic heart failure. There are though still a large number of patients that develop symptoms of heart failure in the form of fatigue and breathlessness with physical exertion in spite of medical treatment. With the advance in stem cell technology there is now hope for the possibility of regenerating/repairing dead myocardial tissue, hence improving cardiac function. The current study is a pilot study that is going to precede a later double blinded randomized study. The aim of the study is to evaluate patient safety, optimize procedures, and to be used in power calculation in the design of the following study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Chestpain
- •Troponin T, \> 0,1ng/ml
- •Succesfull revascularization of culprit lesion with PCI.
- •No more than stenosis of 2 major epicardiel coronary arteries.
Exclusion Criteria
- •Cardiogenic shock
- •Known LVEF\<45%
- •Cardiomyopathy
- •Atrialfibrillation or fluctuation
- •Takyarytmia
- •Infection
- •Chronic inflammatory disease
Outcomes
Primary Outcomes
Safety
Secondary Outcomes
- Change in left ventricular funtion at 4 months followup using contrast enhanced echocardiography