Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells by Mini-Thoracotomy
STEMDILCARD
1 other identifier
interventional
6
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Apr 2004
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2006
CompletedFirst Submitted
Initial submission to the registry
February 1, 2008
CompletedFirst Posted
Study publicly available on registry
February 14, 2008
CompletedFebruary 14, 2008
February 1, 2008
2.5 years
February 1, 2008
February 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
safety: morbidity/mortality
eighteen months
Interventions
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- episodes of tachycardia or ventricular fibrillation
- severe or moderated mitral insufficiency
- any other valvulopathies
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto de Cardiologia do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 906200001, Brazil
Related Publications (1)
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.
PMID: 18553028DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 1, 2008
First Posted
February 14, 2008
Study Start
April 1, 2004
Primary Completion
October 1, 2006
Study Completion
December 1, 2006
Last Updated
February 14, 2008
Record last verified: 2008-02