Brief Title
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy
Official Title
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy in Dilated Cardiomyopathy - Technique and Early Results
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 technique of BMMC transplantation utilizing mini-thoracotomy and results up to one year after the procedure.
Study Phase
Phase 1/Phase 2
Study Type
Interventional
Primary Outcome
safety: morbidity/mortality
Condition
Dilated Cardiomyopathy
Intervention
intramyocardial bone marrow stem cells implantation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
6
Start Date
April 2004
Completion Date
December 2006
Primary Completion Date
October 2006
Eligibility Criteria
Inclusion Criteria: - 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 Criteria: - episodes of tachycardia or ventricular fibrillation - severe or moderated mitral insufficiency - any other valvulopathies
Gender
All
Ages
18 Years - 70 Years
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT00615394
Organization ID
UP3549/04
Study Sponsor
Instituto de Cardiologia do Rio Grande do Sul
Collaborators
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Study Sponsor
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Verification Date
February 2008