Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration

Phase 3

Completed

• Conditions: Left Ventricular Dysfunction

• Registration Number: NCT00938847
• Lead Sponsor: Asklepios proresearch

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2007-10
• Study Completion: 2008-10
• Status Verified: 2009-07
• Study First Submitted: 2009-07-13
• Study First Submitted QC: 2009-07-13
• Last Update Submitted: 2009-07-13
• Study First Posted: 2009-07-14
• Last Update Posted: 2009-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Asklepios Klinik St. Georg, Departement of Cardiology; 🇩🇪 Hamburg, Germany