Clinical trial NCT00275977: Treatment of Myocardial Infarction With Bone Marrow Derived Stem Cells
Official title: Treatment of Myocardial Infarction With Autologous Bone Marrow Derived Stem Cells
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Acute Myocardial Infarction
Keywords: "Stem cell"
"autologous bone marrow transplantation"
"Myocardial infarction"
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2006-01-12
Enrollment: 10
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility 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

Primary outcomes:
measure: Safety
Secondary outcomes:
measure: Change in left ventricular funtion at 4 months followup using contrast enhanced echocardiography
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Department of endocrinology M, Odense University Hospital
Study officials:
affiliation: Department of endocrinology M, Odense University Hospital
name: Moustapha Kassem, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/S0140-6736(04)16626-9.
citation: Schachinger 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. doi: 10.1016/j.jacc.2004.08.014.