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Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration

Primary Purpose

Left Ventricular Dysfunction

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
PCI
Sponsored by
Asklepios proresearch
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Left Ventricular Dysfunction focused on measuring left ventricular dysfunction, myocardial infarction, left ventricular dysfunction (LVDF) after acute myocardial infarction

Eligibility Criteria

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

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

Sites / Locations

  • Asklepios Klinik St. Georg, Departement of Cardiology

Outcomes

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.

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.

Full Information

First Posted
July 13, 2009
Last Updated
July 13, 2009
Sponsor
Asklepios proresearch
Collaborators
Cordis Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT00938847
Brief Title
Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration
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 Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Asklepios proresearch
Collaborators
Cordis Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Left Ventricular Dysfunction
Keywords
left ventricular dysfunction, myocardial infarction, left ventricular dysfunction (LVDF) after acute myocardial infarction

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
PCI
Intervention Description
Stent implantation after acute myocardial infarction
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
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

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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karl-Heinz Kuck, Prof. Dr. med.
Organizational Affiliation
Asklepios Klinik St. Georg, Departement of Cardiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asklepios Klinik St. Georg, Departement of Cardiology
City
Hamburg
ZIP/Postal Code
20099
Country
Germany

12. IPD Sharing Statement

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Bone Marrow Derived Mononuclear Cells For Myocardial Regeneration

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