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Progenitor Cell Therapy in Dilative Cardiomyopathy

Primary Purpose

Heart Failure, Congestive, Cardiomyopathy, Dilated, Stem Cell Transplantation

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
intracoronary infusion of BMC
Sponsored by
Johann Wolfgang Goethe University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure, Congestive

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    LV function (Ejection fraction within 3 months) Simpson

    Secondary Outcome Measures

    Full Information

    First Posted
    January 31, 2006
    Last Updated
    February 17, 2009
    Sponsor
    Johann Wolfgang Goethe University Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00284713
    Brief Title
    Progenitor Cell Therapy in Dilative Cardiomyopathy
    Official Title
    Transplantation Of Progenitor Cells And Recovery Of Left Ventricular Function In Patients With Nonischemic Dilatative Cardiomyopathy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2009
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2004 (undefined)
    Primary Completion Date
    January 2009 (Actual)
    Study Completion Date
    January 2009 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Johann Wolfgang Goethe University Hospital

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Heart Failure, Congestive, Cardiomyopathy, Dilated, Stem Cell Transplantation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1, Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    intracoronary infusion of BMC
    Intervention Description
    catheter delivery of stem cells
    Primary Outcome Measure Information:
    Title
    LV function (Ejection fraction within 3 months) Simpson
    Time Frame
    4 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andreas M Zeiher
    Organizational Affiliation
    Div. of Cardiology, University of Frankfurt, Germany
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    23362308
    Citation
    De Rosa S, Seeger FH, Honold J, Fischer-Rasokat U, Lehmann R, Fichtlscherer S, Schachinger V, Dimmeler S, Zeiher AM, Assmus B. Procedural safety and predictors of acute outcome of intracoronary administration of progenitor cells in 775 consecutive procedures performed for acute myocardial infarction or chronic heart failure. Circ Cardiovasc Interv. 2013 Feb;6(1):44-51. doi: 10.1161/CIRCINTERVENTIONS.112.971705. Epub 2013 Jan 29.
    Results Reference
    derived
    PubMed Identifier
    22936827
    Citation
    Leistner DM, Seeger FH, Fischer A, Roxe T, Klotsche J, Iekushi K, Seeger T, Assmus B, Honold J, Karakas M, Badenhoop K, Frantz S, Dimmeler S, Zeiher AM. Elevated levels of the mediator of catabolic bone remodeling RANKL in the bone marrow environment link chronic heart failure with osteoporosis. Circ Heart Fail. 2012 Nov;5(6):769-77. doi: 10.1161/CIRCHEARTFAILURE.111.966093. Epub 2012 Aug 30.
    Results Reference
    derived
    PubMed Identifier
    22651868
    Citation
    Xu Q, Seeger FH, Castillo J, Iekushi K, Boon RA, Farcas R, Manavski Y, Li YG, Assmus B, Zeiher AM, Dimmeler S. Micro-RNA-34a contributes to the impaired function of bone marrow-derived mononuclear cells from patients with cardiovascular disease. J Am Coll Cardiol. 2012 Jun 5;59(23):2107-17. doi: 10.1016/j.jacc.2012.02.033.
    Results Reference
    derived

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    Progenitor Cell Therapy in Dilative Cardiomyopathy

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