A Phase 2/3 interventional study of intramyocardial bone marrow stem cells implantation in Dilated Cardiomyopathy, sponsored by Instituto de Cardiologia do Rio Grande do Sul. Completed at 1 site in Brazil. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2008-08-29.
Sponsored by Instituto de Cardiologia do Rio Grande do Sul · Phase 2/3, Interventional, and Treatment
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.
1,176 studies on the registry are indexed under Cardiomyopathies; 287 are open to participants now.
This study's enrollment of 30 is below the median of 51 across 609 interventional studies indexed under Cardiomyopathies.
Browse Cardiomyopathies studies →Instituto de Cardiologia do Rio Grande do Sul is the lead sponsor of 74 studies on the registry; 10 are open to participants now.
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Exclusion Criteria:
Interventional
Procedure: intramyocardial bone marrow stem cells implantation
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.
Increase of the ejection function of the left ventricle
Time frame: twelve months
This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.
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Instituto de Cardiologia do Rio Grande do Sul