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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

Tracking Information
First Submitted Date  ICMJE January 10, 2006
First Posted Date  ICMJE January 12, 2006
Last Update Posted Date July 23, 2010
Study Start Date  ICMJE February 2006
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2006)
Safety
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00275977 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2006)
Change in left ventricular funtion at 4 months followup using contrast enhanced echocardiography
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Myocardial Infarction With Bone Marrow Derived Stem Cells
Official Title  ICMJE Treatment of Myocardial Infarction With Autologous Bone Marrow Derived Stem Cells
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Condition  ICMJE Acute Myocardial Infarction
Intervention  ICMJE Procedure: Coronary catherization and stem cell infusion
Study Arms  ICMJE Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 10, 2006)
10
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE March 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00275977
Other Study ID Numbers  ICMJE 020
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Odense University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Moustapha Kassem, MD, Ph.D Department of endocrinology M, Odense University Hospital
PRS Account Odense University Hospital
Verification Date January 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP