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Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration

This study has been completed.
Sponsor:
Collaborator:
Cordis Corporation
Information provided by:
Asklepios proresearch
ClinicalTrials.gov Identifier:
NCT00938847
First received: July 13, 2009
Last updated: NA
Last verified: July 2009
History: No changes posted
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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:

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

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
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: July 13, 2009
Last Updated: July 13, 2009
Health Authority: Germany: Ministry for Social and Family Affairs, Health and Consumer Protection

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, Left
Ventricular Dysfunction
Myocardial Ischemia
 Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013