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Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration

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.
ClinicalTrials.gov Identifier: NCT00938847
Recruitment Status : Completed
First Posted : July 14, 2009
Last Update Posted : July 14, 2009
Sponsor:
Collaborator:
Cordis Corporation
Information provided by:
Asklepios proresearch

Brief Summary:
Evaluative pilot study for safety and feasibility with administration of autologous bone bone marrow derived mononuclear cells by endoventricular catheter into the normal border zone fo the ischemic lesion.

Condition or disease Intervention/treatment Phase
Left Ventricular Dysfunction Device: PCI Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration in Early Left Ventricular Dysfunction After Acute Myocardial Infarction And Successful Percutaneous Coronary Intervention
Study Start Date : February 2006
Primary Completion Date : October 2007
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources


Intervention Details:
    Device: PCI
    Stent implantation after acute myocardial infarction


Primary Outcome Measures :
  1. Demonstration of safety and feasibility of BM-MNC treatment. Investigation of the suitability of endocardial left ventricular electromechanical mapping (LVEMM) with NOGA as endpoint for myocardial regeneration. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Collection of first evidence on the best type and time points for the determination of myocardial regeneration by NOGA and other parameters. [ Time Frame: 12 months ]


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:

  • LVEF <40%
  • PCI at latest 6 hours after infarction
  • BMI >20 kg/m² and <30 kg/m²

Exclusion Criteria:

  • PCI elder than 14 days
  • relevant valvular disease
  • left ventricular dysfunction caused by other reasons than ischemic cardiomyopathy
  • history of stroke, chronic atrial fibrillation, multivessel disease, thromboembolic event
  • scheduled for CABG
  • DM Type 1 & extensive hypercholesterinemia
  • pacemaker
  • systemic disease
  • Pregnancy

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): NCT00938847


Locations
Germany
Asklepios Klinik St. Georg, Departement of Cardiology
Hamburg, Germany, 20099
Sponsors and Collaborators
Asklepios proresearch
Cordis Corporation
Investigators
Principal Investigator: Karl-Heinz Kuck, Prof. Dr. med. Asklepios Klinik St. Georg, Departement of Cardiology

Responsible Party: Prof. Dr. med. Karl-Heinz Kuck, Asklepios Klinik St. Georg, Departement of Cardiology
ClinicalTrials.gov Identifier: NCT00938847     History of Changes
Other Study ID Numbers: 996
2005-003629-19
2508
First Posted: July 14, 2009    Key Record Dates
Last Update Posted: July 14, 2009
Last Verified: July 2009

Keywords provided by Asklepios proresearch:
left ventricular dysfunction
myocardial infarction
left ventricular dysfunction (LVDF) after acute myocardial infarction

Additional relevant MeSH terms:
Myocardial Infarction
Ventricular Dysfunction
Ventricular Dysfunction, Left
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases