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Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration

This study has been completed.
Cordis Corporation
Information provided by:
Asklepios proresearch Identifier:
First received: July 13, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
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 Intervention Phase
Left Ventricular Dysfunction Device: PCI Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by Asklepios proresearch:

Primary Outcome Measures:
  • 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:
  • 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 ]

Enrollment: 20
Study Start Date: February 2006
Study Completion Date: October 2008
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: PCI
    Stent implantation after acute myocardial infarction

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00938847

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

Responsible Party: Prof. Dr. med. Karl-Heinz Kuck, Asklepios Klinik St. Georg, Departement of Cardiology Identifier: NCT00938847     History of Changes
Other Study ID Numbers: 996
Study First Received: July 13, 2009
Last Updated: July 13, 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 processed this record on August 16, 2017