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Progenitor Cell Therapy in Dilative Cardiomyopathy

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ClinicalTrials.gov Identifier: NCT00284713
Recruitment Status : Completed
First Posted : February 1, 2006
Last Update Posted : February 18, 2009
Sponsor:
Information provided by:
Johann Wolfgang Goethe University Hospital

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

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

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  (Clinical Trial)
Estimated Enrollment : 30 participants
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
Study Start Date : May 2004
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cardiomyopathy


Intervention Details:
  • Procedure: intracoronary infusion of BMC
    catheter delivery of stem cells


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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
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

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

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 Posted: February 1, 2006    Key Record Dates
Last Update Posted: February 18, 2009
Last Verified: February 2009

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