Progenitor Cell Therapy in Dilative Cardiomyopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2009-01-31

Brief Summary

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

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Detailed Description

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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

Conditions

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Heart Failure, Congestive Cardiomyopathy, Dilated Stem Cell Transplantation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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intracoronary infusion of BMC

catheter delivery of stem cells

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No