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Treatment of Myocardial Infarction With Bone Marrow Derived Stem Cells

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2006 by Odense University Hospital.
Recruitment status was:  Recruiting
Information provided by:
Odense University Hospital Identifier:
First received: January 10, 2006
Last updated: July 22, 2010
Last verified: January 2006
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.

Condition Intervention Phase
Acute Myocardial Infarction
Procedure: Coronary catherization and stem cell infusion
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Treatment of Myocardial Infarction With Autologous Bone Marrow Derived Stem Cells

Resource links provided by NLM:

Further study details as provided by Odense University Hospital:

Primary Outcome Measures:
  • Safety

Secondary Outcome Measures:
  • Change in left ventricular funtion at 4 months followup using contrast enhanced echocardiography

Estimated Enrollment: 10
Study Start Date: February 2006
Estimated Study Completion Date: March 2007
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.


Ages Eligible for Study:   30 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00275977

Contact: Malthe AM Kristiansen, MD +45 65504081

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

Publications: Identifier: NCT00275977     History of Changes
Other Study ID Numbers: 020
Study First Received: January 10, 2006
Last Updated: July 22, 2010

Keywords provided by Odense University Hospital:
"Stem cell"
"autologous bone marrow transplantation"
"Myocardial infarction"

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on May 25, 2017