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Progenitor Cell Therapy in Dilative Cardiomyopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00284713
First Posted: February 1, 2006
Last Update Posted: February 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Johann Wolfgang Goethe University Hospital
  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
Intervention Model: Single Group Assignment
Masking: None (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 Hospital:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284713


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

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
First Submitted: January 31, 2006
First Posted: February 1, 2006
Last Update Posted: February 18, 2009
Last Verified: February 2009

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


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