Status:
COMPLETED
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy
Lead Sponsor:
Instituto de Cardiologia do Rio Grande do Sul
Collaborating Sponsors:
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Conditions:
Dilated Cardiomyopathy
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This study describes a t...
Eligibility Criteria
Inclusion
- diagnosis made at more than two years and symptomatic at functional class III-IV by the New York Heart Association classification (NYHA) despite optimal pharmacologic therapy
- left ventricular ejection fraction (LVEF) less than 35%, by echocardiogram
- age below 60 years
- absence of neoplasm
- absence of hematologic disease or systemic disease
- no previous cardiac intervention
Exclusion
- episodes of tachycardia or ventricular fibrillation
- severe or moderated mitral insufficiency
- any other valvulopathies
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2006
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00615394
Start Date
April 1 2004
End Date
December 1 2006
Last Update
February 14 2008
Active Locations (1)
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1
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, Brazil, 906200001