Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy (STEMDILCARD)
Primary Purpose
Dilated Cardiomyopathy
Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
intramyocardial bone marrow stem cells implantation
Sponsored by
About this trial
This is an interventional treatment trial for Dilated Cardiomyopathy focused on measuring cardiomyopathy, stem cell, cardiac failure
Eligibility 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
Sites / Locations
- Instituto de Cardiologia do Rio Grande do Sul
Outcomes
Primary Outcome Measures
safety: morbidity/mortality
Secondary Outcome Measures
Full Information
NCT ID
NCT00615394
First Posted
February 1, 2008
Last Updated
February 1, 2008
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
1. Study Identification
Unique Protocol Identification Number
NCT00615394
Brief Title
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy
Acronym
STEMDILCARD
Official Title
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy in Dilated Cardiomyopathy - Technique and Early Results
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Name of the 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
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dilated Cardiomyopathy
Keywords
cardiomyopathy, stem cell, cardiac failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
intramyocardial bone marrow stem cells implantation
Intervention Description
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 Measure Information:
Title
safety: morbidity/mortality
Time Frame
eighteen months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Instituto de Cardiologia do Rio Grande do Sul
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
906200001
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
18553028
Citation
Kalil RA, Ott D, Sant'Anna R, Dias E, Marques-Pereira JP, Delgado-Canedo 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. doi: 10.1590/s1516-31802008000200003.
Results Reference
derived
Learn more about this trial
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy
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