Dilated Cardiomyopathy Clinical Trial
Official title:
Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Dilated Cardiomyopathy
The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy
This protocol describes a double-blind placebo controlled randomized clinical trial to
evaluate the efficacy of bone marrow derived stem cell implants in 300 bazillion patients
with dilated cardiomyopathy and heart failure in class III or IV of the New York Heart
Association.
The primary endpoint of this study is to evaluate the effect of the autologous bone marrow
stem cell implant in the increase of the ejection fraction of the left ventricle in
comparison with a control group, under optimized therapy for dilated cardiomyopathy.
Secondary endpoints will evaluate the alteration in NYHA functional class, mortality rate,
physical capacity (by ergoespirometry), life quality (Minnesota questionnaire) and pulmonary
congestion in dilated cardiomyopathy patients the received the autologous bone-marrow stem
cell implant.
Hypothesis: The main hypothesis of this study is that the patients who received the
autologous bone-marrow stem cell implant will have after a 6 month follow-up a mean 5%
increase in absolute left ventricle ejection fraction in comparison with the control group.
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