Progenitor Cell Therapy in Dilative Cardiomyopathy

Johann Wolfgang Goethe University Hospital

Status and phase: Completed; Phase 2; Phase 1

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

Treatments: Procedure: intracoronary infusion of BMC

Study type: Interventional

Funder types: Other

Identifiers

NCT00284713

TOPCARE-DCM

Details and patient eligibility

About

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

Full 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

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)