Stem Cells and Resynchronization Cardiac
- Conditions
- Heart Failure
- Registration Number
- NCT00800657
- Lead Sponsor
- Instituto de Molestias Cardiovasculares
- Brief Summary
Same patients with dilated myocardiopathies with large areas of fibrosis has not been as successful after Cardiac Resynchronization Therapy, for Heart Failure patients in functional class III or IV. Therefore the investigators have decided to associate the Stem-Cell implant with Cardiac Resynchronization Therapy in these patients.
- Detailed Description
About 120cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution the mononuclear cells are injected into the cardiac muscles with fibroses area through 20 shots.This procedure is indicated for patients with cardiac ischemia and left ventricular dysfunction(desynchrony), on whom all the others known therapies have failed.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 30
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Ejection Fraction(EF)-(Eco- Sympson):It is the comparison of these measurements between late pre and post operative. NYHA: Comparison of these measurements between late pre and post operative. 24 months
- Secondary Outcome Measures
Name Time Method Ejection Fraction (Echo/Sympson) and functional class(NYHA). 24 months.
Trial Locations
- Locations (1)
Imc - Instituto de Moléstias Cardiovasculares
🇧🇷São José do Rio Preto, São Paulo, Brazil