NCT00349271

Cell Therapy in Chagas Cardiomyopathy

Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Chagas Cardiomyopathy

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 182 (actual)
• Sponsor: Ministry of Health, Brazil · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine effect of cell therapy in patients with severe dilated cardiomyopathy

Detailed description

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.

Conditions

• Chagas Cardiomyopathy

Interventions

Type	Name	Description
PROCEDURE	Stem cell	Stem cell
DRUG	Filgrastime (G-CSF)	Filgrastime (G-CSF)
DRUG	Standart therapy	All drug with clinical evidence of benefical effect in Chagas disease

Timeline

• Start date: 2006-01-01
• Primary completion: 2010-12-01
• Completion: 2011-12-01
• First posted: 2006-07-06
• Last updated: 2017-03-13

Locations

1 site across 1 country: Brazil