Progenitor Cell Therapy in Dilative Cardiomyopathy

February 17, 2009 updated by: Johann Wolfgang Goethe University Hospital

Transplantation Of Progenitor Cells And Recovery Of Left Ventricular Function In Patients With Nonischemic Dilatative Cardiomyopathy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: intracoronary infusion of BMC

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 Type

Interventional

Enrollment (Anticipated)

Phase

Phase 2
Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
LV function (Ejection fraction within 3 months) Simpson Time Frame: 4 months	4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johann Wolfgang Goethe University Hospital

Investigators

Principal Investigator: Andreas M Zeiher, Div. of Cardiology, University of Frankfurt, Germany

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

January 31, 2006

First Submitted That Met QC Criteria