Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration in Early Left Ventricular Dysfunction After Acute Myocardial Infarction And Successful Percutaneous Coronary Intervention

Asklepios proresearch1 site in 1 country20 target enrollmentFebruary 2006

ConditionsLeft Ventricular Dysfunction

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Left Ventricular Dysfunction
Sponsor: Asklepios proresearch
Enrollment: 20
Locations: 1
Primary Endpoint: 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.
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

February 2006

End Date

October 2008

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Asklepios proresearch

Eligibility Criteria

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

Outcomes

Primary Outcomes

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 Outcomes

Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters.(12 months)