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

This study has been completed.
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Instituto de Cardiologia do Rio Grande do Sul
ClinicalTrials.gov Identifier:
NCT00743639
First received: August 28, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted

August 28, 2008
August 28, 2008
July 2005
June 2006   (final data collection date for primary outcome measure)
Increase of the ejection function of the left ventricle [ Time Frame: twelve months ] [ Designated as safety issue: Yes ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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

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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Dilated Cardiomyopathy
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.
1
Interventional
Intervention: Procedure: intramyocardial bone marrow stem cells implantation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
June 2008
June 2006   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT00743639
UP3758
Yes
James Fracasso, Instituto de Cardiologia do Rio Grande do Sul / Fund. Universit. Cardiologia
Instituto de Cardiologia do Rio Grande do Sul
  • Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
Study Director: Renato AK Kalil, MD, PhD Institute of Cardiology of Rio Grande do Sul / FUC
Instituto de Cardiologia do Rio Grande do Sul
June 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP