Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration

Overview

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.

Full Title of Study: “Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration in Early Left Ventricular Dysfunction After Acute Myocardial Infarction And Successful Percutaneous Coronary Intervention”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2007

Interventions

  • Device: PCI
    • Stent implantation after acute myocardial infarction

Clinical Trial Outcome Measures

Primary 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 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Asklepios proresearch
  • Collaborator
    • Cordis Corporation
  • Provider of Information About this Clinical Study
    • Prof. Dr. med. Karl-Heinz Kuck, Asklepios Klinik St. Georg, Departement of Cardiology
  • Overall Official(s)
    • Karl-Heinz Kuck, Prof. Dr. med., Principal Investigator, Asklepios Klinik St. Georg, Departement of Cardiology

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.