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Completed

NCT Number: NCT00615394

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

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.

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Key information

Conditions

Dilated Cardiomyopathy Cardiomegaly Cardiomyopathies Cardiomyopathy, Dilated Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heart Diseases Heart Failure Laminopathies

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Instituto de Cardiologia do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 906200001, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

intramyocardial bone marrow stem cells implantation

Procedure

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 outcomes

  1. safety: morbidity/mortality

    Time frame: eighteen months

Sponsors and collaborators

Lead sponsor

Instituto de Cardiologia do Rio Grande do Sul

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico
  • Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul, Brazil

Registry information

Official study title

Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy in Dilated Cardiomyopathy - Technique and Early Results

Acronym: STEMDILCARD

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Feb 14, 2008
Registry last updated
Feb 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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