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

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:
NCT00615394
First received: February 1, 2008
Last updated: NA
Last verified: February 2008
History: No changes posted
  Purpose

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 Intervention Phase
Dilated Cardiomyopathy
Procedure: intramyocardial bone marrow stem cells implantation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Instituto de Cardiologia do Rio Grande do Sul:

Primary Outcome Measures:
  • safety: morbidity/mortality [ Time Frame: eighteen months ] [ Designated as safety issue: Yes ]

Enrollment: 6
Study Start Date: April 2004
Study Completion Date: December 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Instituto de Cardiologia do Rio Grande do Sul

Additional 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
Study First Received: February 1, 2008
Last Updated: February 1, 2008
Health Authority: Brasil:CONEP, National Ethical Committee

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

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

ClinicalTrials.gov processed this record on July 28, 2014