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Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy (STEMDILCARD)

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ClinicalTrials.gov Identifier: NCT00615394
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : February 14, 2008
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

Brief Summary:
Bone marrow mononuclear cells (BMMC) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.This study describes a technique of BMMC transplantation utilizing mini-thoracotomy and results up to one year after the procedure.

Condition or disease Intervention/treatment Phase
Dilated Cardiomyopathy Procedure: intramyocardial bone marrow stem cells implantation Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy in Dilated Cardiomyopathy - Technique and Early Results
Study Start Date : April 2004
Primary Completion Date : October 2006
Study Completion Date : December 2006



Intervention Details:
    Procedure: intramyocardial bone marrow stem cells implantation
    Patients with previous diagnosis of non-ischemic dilated cardiomyopathy. were included. Bone-marrow was collected from in the antero-superior iliac crest and mononuclear stem-cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Surgical technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5 ml), in the anterior, lateral, posterior and apical faces of the left ventricle(average 9.6 ± 2.6 x 107 cells). After the procedure, the patients were kept in the post-operative intensive care unit for a minimum period of 24 hours. They were released from the hospital in a period that varied from five to seven days.


Primary Outcome Measures :
  1. safety: morbidity/mortality [ Time Frame: eighteen months ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis made at more than two years 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 60 years
  • absence of neoplasm
  • absence 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615394


Locations
Brazil
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, RS, Brazil, 906200001
Sponsors and Collaborators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Instituto de Cardiologia do Rio Grande do Sul / Fundação Universitária de Cardiologia
ClinicalTrials.gov Identifier: NCT00615394     History of Changes
Other Study ID Numbers: UP3549/04
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: February 14, 2008
Last Verified: February 2008

Keywords provided by Instituto de Cardiologia do Rio Grande do Sul:
cardiomyopathy, stem cell, cardiac failure

Additional relevant MeSH terms:
Cardiomyopathies
Cardiomyopathy, Dilated
Heart Diseases
Cardiovascular Diseases
Cardiomegaly