Progenitor Cell Therapy in Dilative Cardiomyopathy

This study has been completed.
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospitals
ClinicalTrials.gov Identifier:
NCT00284713
First received: January 31, 2006
Last updated: February 17, 2009
Last verified: February 2009
  Purpose

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


Condition Intervention Phase
Heart Failure, Congestive
Cardiomyopathy, Dilated
Stem Cell Transplantation
Procedure: intracoronary infusion of BMC
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transplantation Of Progenitor Cells And Recovery Of Left Ventricular Function In Patients With Nonischemic Dilatative Cardiomyopathy

Resource links provided by NLM:


Further study details as provided by Johann Wolfgang Goethe University Hospitals:

Primary Outcome Measures:
  • LV function (Ejection fraction within 3 months) Simpson [ Time Frame: 4 months ]

Estimated Enrollment: 30
Study Start Date: May 2004
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: intracoronary infusion of BMC
    catheter delivery of stem cells
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00284713

Sponsors and Collaborators
Johann Wolfgang Goethe University Hospitals
Investigators
Principal Investigator: Andreas M Zeiher Div. of Cardiology, University of Frankfurt, Germany
  More Information

No publications provided by Johann Wolfgang Goethe University Hospitals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00284713     History of Changes
Other Study ID Numbers: TOPCARE-DCM
Study First Received: January 31, 2006
Last Updated: February 17, 2009
Health Authority: Germany: Paul-Ehrlich-Institut

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated
Heart Failure
Cardiomegaly
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014