Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy
Information source: Instituto de Cardiologia do Rio Grande do Sul
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Dilated Cardiomyopathy
Intervention: intramyocardial bone marrow stem cells implantation (Procedure)
Phase: Phase 1/Phase 2
Status: Completed
Sponsored by: Instituto de Cardiologia do Rio Grande do Sul
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.
Clinical Details
Official title: Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy in Dilated Cardiomyopathy - Technique and Early Results
Study design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Primary outcome: safety: morbidity/mortality
Eligibility
Minimum age: 18 Years.
Maximum age: 70 Years.
Gender(s): Both.
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
Locations and Contacts
Instituto de Cardiologia do Rio Grande do Sul, Porto Alegre, RS 906200001, Brazil
Additional Information
Starting date: April 2004
Ending date: December 2006
Last updated: February 1, 2008
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