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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
182
Stem cell
Filgrastime (G-CSF)
All drug with clinical evidence of benefical effect in Chagas disease
INCL - National Institute of Cardiology Laranjeiras
Rio de Janeiro, Rio de Janeiro, Brazil
increase of the ejection fraction of the left ventricle
Time frame: 1 year
Death by any cause within 1 year of intervention
Time frame: 1 year
Difference in life quality as estimated by Minnesota living with Heart Failure Questionnaire at six months and baseline
Time frame: 1 year
Difference in NYHA functional class at six months and baseline
Time frame: six months
Percent number of patients that reached an absolute increase of 5% in ejection fraction at six and twelve months
Time frame: 1 year
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