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

Dilated Cardiomyopathy Clinical Trial

— SDILCM  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00743639
• Other study ID #: UP3758
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 28, 2008
• Last updated: August 28, 2008
• Start date: July 2005
• Est. completion date: June 2008

Study information

• Verified date: June 2008
• Source: Instituto de Cardiologia do Rio Grande do Sul
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2008
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiomyopathies
• Cardiomyopathy, Dilated
• Dilated Cardiomyopathy

Intervention

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.

Locations

Country	Name	City	State
Brazil	Institute of Cardiology of Rio Grande do Sul / FUC	Porto Alegre	Rio Grande do Sul

Sponsors (3)

Lead Sponsor	Collaborator
Instituto de Cardiologia do Rio Grande do Sul	Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase of the ejection function of the left ventricle		twelve months	Yes