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

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

This study has been completed.

First Received on February 1, 2008. No Changes Posted

Sponsor:	Instituto de Cardiologia do Rio Grande do Sul
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

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 I Phase II

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:

MedlinePlus related topics: Bone Grafts Bone Marrow Transplantation Cardiomyopathy

U.S. FDA Resources

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:

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

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):

Kalil RA, Ott D, Sant'Anna R, Dias E, Marques-Pereira JP, Delgado-Cañedo A, Nardi NB, Sant'Anna JR, Prates PR, Nesralla I. Autologous transplantation of bone marrow mononuclear stem cells by mini-thoracotomy in dilated cardiomyopathy: technique and early results. Sao Paulo Med J. 2008 Mar 6;126(2):75-81.

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 February 09, 2012