Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration
Overview
Evaluative pilot study for safety and feasibility with administration of autologous bone bone marrow derived mononuclear cells by endoventricular catheter into the normal border zone fo the ischemic lesion.
Full Title of Study: “Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration in Early Left Ventricular Dysfunction After Acute Myocardial Infarction And Successful Percutaneous Coronary Intervention”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Primary Purpose: Basic Science
- Masking: None (Open Label)
- Study Primary Completion Date: October 2007
Interventions
- Device: PCI
- Stent implantation after acute myocardial infarction
Clinical Trial Outcome Measures
Primary Measures
- Demonstration of safety and feasibility of BM-MNC treatment. Investigation of the suitability of endocardial left ventricular electromechanical mapping (LVEMM) with NOGA as endpoint for myocardial regeneration.
- Time Frame: 12 months
Secondary Measures
- Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.
- Time Frame: 12 months
Participating in This Clinical Trial
Inclusion Criteria
- LVEF <40% – PCI at latest 6 hours after infarction – BMI >20 kg/m² and <30 kg/m² Exclusion Criteria:
- PCI elder than 14 days – relevant valvular disease – left ventricular dysfunction caused by other reasons than ischemic cardiomyopathy – history of stroke, chronic atrial fibrillation, multivessel disease, thromboembolic event – scheduled for CABG – DM Type 1 & extensive hypercholesterinemia – pacemaker – systemic disease – Pregnancy
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 80 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Asklepios proresearch
- Collaborator
- Cordis Corporation
- Provider of Information About this Clinical Study
- Prof. Dr. med. Karl-Heinz Kuck, Asklepios Klinik St. Georg, Departement of Cardiology
- Overall Official(s)
- Karl-Heinz Kuck, Prof. Dr. med., Principal Investigator, Asklepios Klinik St. Georg, Departement of Cardiology
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