Treatment of Myocardial Infarction With Bone Marrow Derived Stem Cells

July 22, 2010 updated by: Odense University Hospital

Treatment of Myocardial Infarction With Autologous Bone Marrow Derived Stem Cells

The aim of the study is to investigate whether infusion of autologous bone marrow derived stem cells can improve cardiac function in the aftermath of a myocardial infarction.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Primary coronary intervention within a few hours of a myocardial infarction has greatly reduced mortality as well as the risk of developing chronic heart failure. There are though still a large number of patients that develop symptoms of heart failure in the form of fatigue and breathlessness with physical exertion in spite of medical treatment. With the advance in stem cell technology there is now hope for the possibility of regenerating/repairing dead myocardial tissue, hence improving cardiac function.

The current study is a pilot study that is going to precede a later double blinded randomized study. The aim of the study is to evaluate patient safety, optimize procedures, and to be used in power calculation in the design of the following study.

Study Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Odense, Denmark, 5000
        • Recruiting
        • Department of endocrinology M, Odense University Hospital
        • Sub-Investigator:
          • Malthe AM Kristiansen, MD
        • Principal Investigator:
          • Moustapha Kassem, MD, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Chestpain
  • Troponin T, > 0,1ng/ml
  • Succesfull revascularization of culprit lesion with PCI.
  • No more than stenosis of 2 major epicardiel coronary arteries.

Exclusion Criteria:

  • Cardiogenic shock
  • Known LVEF<45%
  • Cardiomyopathy
  • Atrialfibrillation or fluctuation
  • Takyarytmia
  • Infection
  • Chronic inflammatory disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety

Secondary Outcome Measures

Outcome Measure
Change in left ventricular funtion at 4 months followup using contrast enhanced echocardiography

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Odense University Hospital

Investigators

  • Principal Investigator: Moustapha Kassem, MD, Ph.D, Department of endocrinology M, Odense University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Study Completion

March 1, 2007

Study Registration Dates

First Submitted

January 10, 2006

First Submitted That Met QC Criteria

January 10, 2006

First Posted (Estimate)

January 12, 2006

Study Record Updates

Last Update Posted (Estimate)

July 23, 2010

Last Update Submitted That Met QC Criteria

July 22, 2010

Last Verified

January 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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