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Treatment of Myocardial Infarction With Bone Marrow Derived Stem Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00275977
Recruitment Status : Unknown
Verified January 2006 by Odense University Hospital.
Recruitment status was:  Recruiting
First Posted : January 12, 2006
Last Update Posted : July 23, 2010
Sponsor:
Information provided by:
Odense University Hospital

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Acute Myocardial Infarction Procedure: Coronary catherization and stem cell infusion Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Treatment of Myocardial Infarction With Autologous Bone Marrow Derived Stem Cells
Study Start Date : February 2006
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Safety

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

Eligibility Criteria
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Information from the National Library of Medicine

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

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275977


Contacts
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Contact: Malthe AM Kristiansen, MD +45 65504081 mkristiansen@health.sdu.dk

Locations
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Denmark
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
Investigators
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Principal Investigator: Moustapha Kassem, MD, Ph.D Department of endocrinology M, Odense University Hospital
More Information
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Publications:

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ClinicalTrials.gov Identifier: NCT00275977    
Other Study ID Numbers: 020
First Posted: January 12, 2006    Key Record Dates
Last Update Posted: July 23, 2010
Last Verified: January 2006
Keywords provided by Odense University Hospital:
"Stem cell"
"autologous bone marrow transplantation"
"Myocardial infarction"
Additional relevant MeSH terms:
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Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
 Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases