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| Name | Class |
|---|---|
| Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil | OTHER |
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Other | Interventional |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intramyocardial bone marrow stem cells implantation | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Increase of the ejection function of the left ventricle | twelve months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Renato AK Kalil, MD, PhD | Institute of Cardiology of Rio Grande do Sul / FUC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Cardiology of Rio Grande do Sul / FUC | Porto Alegre | Rio Grande do Sul | 90620001 | Brazil |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| D009202 | Cardiomyopathies |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D000083083 | Laminopathies |
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |