Treatment of Myocardial Infarction With Bone Marrow Derived Stem Cells

Acute Myocardial Infarction Clinical Trial

Official title:

Treatment of Myocardial Infarction With Autologous Bone Marrow Derived Stem Cells

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00275977
• Other study ID #: 020
• Status: Recruiting
• Phase: Phase 1
• First received: January 10, 2006
• Last updated: July 22, 2010
• Start date: February 2006
• Est. completion date: March 2007

Study information

• Verified date: January 2006
• Source: Odense University Hospital
• Contact: Malthe AM Kristiansen, MD
• Phone: +45 65504081
• Email: mkristiansen[@]health.sdu.dk
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Procedure:
• Coronary catherization and stem cell infusion

Locations

Country	Name	City	State
Denmark	Department of endocrinology M, Odense University Hospital	Odense

Sponsors (1)

Lead Sponsor	Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

Schächinger V, Assmus B, Britten MB, Honold J, Lehmann R, Teupe C, Abolmaali ND, Vogl TJ, Hofmann WK, Martin H, Dimmeler S, Zeiher AM. Transplantation of progenitor cells and regeneration enhancement in acute myocardial infarction: final one-year results of the TOPCARE-AMI Trial. J Am Coll Cardiol. 2004 Oct 19;44(8):1690-9. — View Citation

Wollert KC, Meyer GP, Lotz J, Ringes-Lichtenberg S, Lippolt P, Breidenbach C, Fichtner S, Korte T, Hornig B, Messinger D, Arseniev L, Hertenstein B, Ganser A, Drexler H. Intracoronary autologous bone-marrow cell transfer after myocardial infarction: the BOOST randomised controlled clinical trial. Lancet. 2004 Jul 10-16;364(9429):141-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety
Secondary	Change in left ventricular funtion at 4 months followup using contrast enhanced echocardiography