Progenitor Cell Therapy in Dilative Cardiomyopathy

Johann Wolfgang Goethe University Hospital30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Heart Failure, Congestive Cardiomyopathy, Dilated Stem Cell Transplantation

Interventions

intracoronary infusion of BMCPROCEDURE

catheter delivery of stem cells

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

LV function (Ejection fraction within 3 months) Simpson

Time frame: 4 months

Data from ClinicalTrials.gov

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