Dilated Cardiomyopathy
Conditions
Keywords
cardiomyopathy, stem cell, cardiac failure
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.
Interventions
Patients with previous diagnosis of non-ischemic dilated cardiomyopathy. were included. Bone-marrow was collected from in the antero-superior iliac crest and mononuclear stem-cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Surgical technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5 ml), in the anterior, lateral, posterior and apical faces of the left ventricle(average 9.6 ± 2.6 x 107 cells). After the procedure, the patients were kept in the post-operative intensive care unit for a minimum period of 24 hours. They were released from the hospital in a period that varied from five to seven days.
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety: morbidity/mortality | eighteen months |
Countries
Brazil