Treatment of Myocardial Infarction With Bone Marrow Derived Stem Cells

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Odense University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Odense University Hospital
ClinicalTrials.gov Identifier:
NCT00275977
First received: January 10, 2006
Last updated: July 22, 2010
Last verified: January 2006
  Purpose

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
Endpoint Classification: Safety Study
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.

  Eligibility

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00275977

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

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

Publications:
ClinicalTrials.gov Identifier: NCT00275977     History of Changes
Other Study ID Numbers: 020
Study First Received: January 10, 2006
Last Updated: July 22, 2010
Health Authority: Denmark: National Board of Health

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on September 15, 2014