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

Sponsor:	Instituto de Cardiologia do Rio Grande do Sul
Collaborators:	FAPERGS CNPq
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:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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, RS
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, RS, Brazil, 906200001

Sponsors and Collaborators

Instituto de Cardiologia do Rio Grande do Sul

FAPERGS

CNPq

More Information

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

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):

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
Study ID Numbers:	UP3549/04
Study First Received:	February 1, 2008
Last Updated:	February 1, 2008
ClinicalTrials.gov Identifier:	NCT00615394 History of Changes
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:

Heart Diseases
Cardiomyopathy, Dilated
Cardiovascular Diseases
Cardiomegaly
Cardiomyopathies

ClinicalTrials.gov processed this record on November 09, 2009