Multicenter randomized trial of cell therapy in cardiopathies - MiHeart Study.
BACKGROUND
Cardiovascular diseases are the major cause of death in the world. Current treatments have not been able to reverse this scenario, creating the need for the development of new therapies. Cell therapies have emerged as an alternative for cardiac diseases of distinct causes in experimental animal studies and more recently in clinical trials.


METHODS
We have designed clinical trials to test for the efficacy of autologous bone marrow derived mononuclear cell therapies in four different cardiopathies: acute and chronic ischemic heart disease, and Chagasic and dilated cardiomyopathy. All trials are multicenter, randomized, double-blind and placebo controlled. In each trial 300 patients will be enrolled and receive optimized therapy for their specific condition. Additionally, half of the patients will receive the autologous bone marrow cells while the other half will receive placebo (saline with 5% autologous serum). For each trial there are specific inclusion and exclusion criteria and the method for cell delivery is intramyocardial for the chronic ischemic heart disease and intracoronary for all others. Primary endpoint for all studies will be the difference in ejection fraction (determined by Simpson's rule) six and twelve months after intervention in relation to the basal ejection fraction. The main hypothesis of this study is that the patients who receive the autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean increase of 5% in absolute left ventricular ejection fraction in comparison with the control group.


CONCLUSIONS
Many phase I clinical trials using cell therapy for cardiac diseases have already been performed. The few randomized studies have yielded conflicting results, rendering necessary larger well controlled trials to test for efficacy of cell therapies in cardiopathies. The trials registration numbers at the NIH registry are the following: Chagasic cardiomyopathy (NCT00349271), dilated cardiomyopathy (NCT00333827), acute myocardial infarction (NCT00350766) and Chronic Ischemic Heart Disease (NCT00362388).
Tura
Bernardo R
BR
Instituto Nacional de Cardiologia Laranjeiras, Rio de Janeiro, Brazil. tura@centroin.com.br
Martino
Helena F
HF
Gowdak
Luis H
LH
dos Santos
Ricardo Ribeiro
RR
Dohmann
Hans F
HF
Krieger
José E
JE
Feitosa
Gilson
G
Vilas-Boas
Fábio
F
Oliveira
Sérgio A
SA
Silva
Suzana A
SA
Bozza
Augusto Z
AZ
Borojevic
Radovan
R
de Carvalho
Antonio C Campos
AC