Affordable Access

Access to the full text

M ulticenter randomi zed trial of cell the rapy in car diopat hies – MiHeart Study

Authors
  • Tura, Bernardo R1
  • Martino, Helena F1
  • Gowdak, Luis H2
  • dos Santos, Ricardo Ribeiro3
  • Dohmann, Hans F4
  • Krieger, José E2
  • Feitosa, Gilson5
  • Vilas-Boas, Fábio5
  • Oliveira, Sérgio A2
  • Silva, Suzana A4
  • Bozza, Augusto Z1
  • Borojevic, Radovan6
  • de Carvalho, Antonio C Campos1
  • 1 Instituto Nacional de Cardiologia Laranjeiras, Rio de Janeiro, Brazil , Rio de Janeiro (Brazil)
  • 2 Instituto do Coração da Universidade de São Paulo, São Paulo, Brazil , São Paulo (Brazil)
  • 3 Centro de Pesquisa Gonçalo Muniz-Fiocruz, Salvador, Brazil , Salvador (Brazil)
  • 4 Hospital Pró-Cardíaco, Rio de Janeiro, Brazil , Rio de Janeiro (Brazil)
  • 5 Hospital Santa Izabel-Santa Casa de Misericórida da Bahia, Salvador, Brazil , Salvador (Brazil)
  • 6 Universidade Federal do Rio de Janeiro, Rio de Janeiro, Brazil , Rio de Janeiro (Brazil)
Type
Published Article
Journal
Trials
Publisher
Springer (Biomed Central Ltd.)
Publication Date
Jan 18, 2007
Volume
8
Issue
1
Identifiers
DOI: 10.1186/1745-6215-8-2
Source
Springer Nature
Keywords
License
Yellow

Abstract

BackgroundCardiovascular 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.Method/DesignWe 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.DiscussionMany 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).

Report this publication

Statistics

Seen <100 times