Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy
Phase 2
Completed
- Conditions
- Dilated Cardiomyopathy
- Interventions
- Procedure: intramyocardial bone marrow stem cells implantation
- Registration Number
- NCT00743639
- Lead Sponsor
- Instituto de Cardiologia do Rio Grande do Sul
- 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 failure class III or NYHA.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- 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 Criteria
- Episodes of tachycardia or ventricular fibrillation
- Severe or moderated mitral insufficiency
- Any other valvulopathies
- Previous cardiac surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 intramyocardial bone marrow stem cells implantation Interventional
- Primary Outcome Measures
Name Time Method Increase of the ejection function of the left ventricle twelve months
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Institute of Cardiology of Rio Grande do Sul / FUC
🇧🇷Porto Alegre, Rio Grande do Sul, Brazil