Dilated Cardiomyopathy
Conditions
Keywords
Cardiomyopathy, stem cell, cardiac failure
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.
Interventions
Control group: the patients will be monitored with regular medical visits. Echocardiography: baseline,3,6,9 months. Cardiac NMR at baseline, 3 and 9 months. Interventional group: Bone-marrow was collected from in the anterior-superior iliac crest and mononuclear stem cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5ml), in the anterior, lateral, posterior and apical faces of the LV ((average 9.6±2.6 x 10\[7\] cells). After the procedure, the patients were kept in the p.o. for a minimum period of 24hrs. They were released from the hospital in a period that varied from 5-7 days.
Sponsors
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Instituto de Cardiologia do Rio Grande do Sul
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Increase of the ejection function of the left ventricle | twelve months |
Countries
Brazil
Outcome results
None listed