NCT00333827

Cell Therapy In Dilated Cardiomyopathy

Multicenter Randomized Study Of Cell Therapy In Cardiopathies - Dilated Cardiomyopathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 115 (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. 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.

Conditions

• Dilated Cardiomyopathy

Interventions

Type	Name	Description
DRUG	optimal therapy for cardiaca failure	optimal therapy for cardiaca failure
PROCEDURE	cell	stem cell

Timeline

• Start date: 2006-01-01
• Primary completion: 2012-12-01
• Completion: 2013-02-01
• First posted: 2006-06-06
• Last updated: 2017-03-13

Locations

1 site across 1 country: Brazil