Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy (SDILCM)
Primary Purpose
Dilated Cardiomyopathy
Status
Completed
Phase
Phase 2
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 one year 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 70 years
- Absence of neoplasm
- Abscence 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
- Previous cardiac surgery
Sites / Locations
- Institute of Cardiology of Rio Grande do Sul / FUC
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
1
Arm Description
Interventional
Outcomes
Primary Outcome Measures
Increase of the ejection function of the left ventricle
Secondary Outcome Measures
Full Information
NCT ID
NCT00743639
First Posted
August 28, 2008
Last Updated
August 28, 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
NCT00743639
Brief Title
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy
Acronym
SDILCM
Official Title
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy: Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
June 2008 (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
This study describes a controlled randomized clinical trial to evaluate the efficacy of bone marrow derived stem-cell implants by minithoracotomy in patients with dilated cardiomyopathy and cardiac failure class III or NYHA.
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 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Other
Arm Description
Interventional
Intervention Type
Procedure
Intervention Name(s)
intramyocardial bone marrow stem cells implantation
Intervention Description
Control group: the patients will be monitored with regular medical visits. Echocardiography: baseline,3,6,9 months. Cardiac NMR at baseline, 3 and 9 months.
Interventional group: Bone-marrow was collected from in the anterior-superior iliac crest and mononuclear stem cells were isolated by centrifugation in the density rate Ficoll-Hypaque 1.077 media. Technique - The approach was through a left mini-thoracotomy. Twenty small injections of cellular suspension were directly made through a 21F butterfly needle(total=5ml), in the anterior, lateral, posterior and apical faces of the LV ((average 9.6±2.6 x 10[7] cells). After the procedure, the patients were kept in the p.o. for a minimum period of 24hrs. They were released from the hospital in a period that varied from 5-7 days.
Primary Outcome Measure Information:
Title
Increase of the ejection function of the left ventricle
Time Frame
twelve 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 one year 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 70 years
Absence of neoplasm
Abscence 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
Previous cardiac surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato AK Kalil, MD, PhD
Organizational Affiliation
Institute of Cardiology of Rio Grande do Sul / FUC
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Cardiology of Rio Grande do Sul / FUC
City
Porto Alegre
State/Province
Rio Grande do Sul
ZIP/Postal Code
90620001
Country
Brazil
12. IPD Sharing Statement
Learn more about this trial
Autologous Transplantation of Bone Marrow Mononuclear Stem-Cells for Dilated Cardiomyopathy
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