Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration

Asklepios proresearch

Status and phase: Completed; Phase 3

Conditions: Left Ventricular Dysfunction

Treatments: Device: PCI

Study type: Interventional

Funder types: Industry

Identifiers

NCT00938847

996

2508

2005-003629-19

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)