Status:
COMPLETED
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy
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:
PHASE2
PHASE3
Brief Summary
This study describes a controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem-cell implants by minithoracotomy in patients with dilated cardiomyopathy and cardiac fa...
Eligibility Criteria
Inclusion
- Diagnosis made at more than one year 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 70 years
- Absence of neoplasm
- Abscence 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
- Previous cardiac surgery
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00743639
Start Date
July 1 2005
End Date
June 1 2008
Last Update
August 29 2008
Active Locations (1)
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1
Institute of Cardiology of Rio Grande do Sul / FUC
Porto Alegre, Rio Grande do Sul, Brazil, 90620001