Progenitor Cell Therapy in Dilative Cardiomyopathy

Phase 1

Completed

• Conditions: Heart Failure, Congestive; Cardiomyopathy, Dilated; Stem Cell Transplantation

• Registration Number: NCT00284713
• Lead Sponsor: Johann Wolfgang Goethe University Hospital

Brief Summary

Intracoronary infusion of bone marrow derived progenitor cells into the LAD in patients with non ischemic dilated cardiomyopathy.

Detailed Description

Initial clinical pilot trials suggested that intracoronary infusion of bone marrow-derived progenitor cells (BMC) may enhance left ventricular functional recovery in patients with acute myocardial infarction. It is unknown, however, whether such a strategy might also be applicable to patients with non-ischemic dilated cardiomyopathy (DCM). Therefore, we initiated the TOPCARE-DCM - trial (Transplantation Of Progenitor Cells And Recovery of Left Ventricular Function in Patients with non ischemic Dilatative CardioMyopathy) aiming to regionally improve left ventricular contractility by selective infusion of BMC into the left anterior descending coronary artery.

Patients will be randomized 2:1 (20/10) BMC Infusion versus standard medical therapy

Study Timeline

• Study Start: 2004-05
• Study First Submitted: 2006-01-31
• Study First Submitted QC: 2006-01-31
• Study First Posted: 2006-02-01
• Primary Completion: 2009-01
• Study Completion: 2009-01
• Status Verified: 2009-02
• Last Update Submitted: 2009-02-17
• Last Update Posted: 2009-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Age 8-80
• Dilated Cardiomyopathy, Ejection fraction < 40%
• LVEDD > 60mm
• Stable clinical condition within last 6 months
• Written informed consent

Exclusion Criteria

• Myocardial infarction or coronary intervention in the past
• Change of medical therapy within the last 6 weeks prior to cell therapy
• Tumor within last 5 years or incomplete remission
• Active infection
• Active bleeding
• Stroke within last 2 years
• Surgery or trauma within last 2 months
• Uncontrolled hypertension
• HIV infection
• Chronic inflammatory disease
• Liver disease (GOT > 2x upper normal limit)
• Renal dysfunction (creatinin > 2.0mg/dl)
• Thrombopenia < 100.000
• Anemia (hemoglobin < 8.5 g/dl)
• Mental retardation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
LV function (Ejection fraction within 3 months) Simpson	4 months