NCT00743639

Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy

Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy: Randomized Clinical Trial

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Instituto de Cardiologia do Rio Grande do Sul · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dilated Cardiomyopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2005-07-01
• Primary completion: 2006-06-01
• Completion: 2008-06-01
• First posted: 2008-08-29
• Last updated: 2008-08-29

Locations

1 site across 1 country: Brazil