Back to resultsStem Cells and Resynchronization Cardiac (RCT and SCT)
Primary Purpose
Heart Failure
Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Pacing and Stem Cells Implantations.
Pacing and Stem Cells Implantation
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure focused on measuring Cardiac Resynchronization, Dilated Cardiomyopathy, Stem Cells Therapy, Heart Failure, Stem Cells/Cardiac Pacing, Artificial
Eligibility Criteria
- Dilated Cardiomyopathy
- Heart Failure
- Optimized Therapeutics
- Ventricular Desynchrony
- Functional Class III or IV
- Ejection Fraction(Echo/ Sympson) < 35%
Sites / Locations
- Imc - Instituto de Moléstias CardiovascularesRecruiting
Outcomes
Primary Outcome Measures
Ejection Fraction(EF)-(Eco- Sympson):It is the comparison of these measurements between late pre and post operative. NYHA: Comparison of these measurements between late pre and post operative.
Secondary Outcome Measures
Ejection Fraction (Echo/Sympson) and functional class(NYHA).
Full Information
NCT ID
NCT00800657
First Posted
November 12, 2008
Last Updated
June 22, 2011
Sponsor
Instituto de Molestias Cardiovasculares
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT00800657
Brief Title
Stem Cells and Resynchronization Cardiac
Acronym
RCT and SCT
Official Title
Stem-Cells and Heart Failure in Several Ethiologies. Alternative Indication With Cardiac Resynchronization
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Instituto de Molestias Cardiovasculares
Collaborators
Medtronic
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Same patients with dilated myocardiopathies with large areas of fibrosis has not been as successful after Cardiac Resynchronization Therapy, for Heart Failure patients in functional class III or IV. Therefore the investigators have decided to associate the Stem-Cell implant with Cardiac Resynchronization Therapy in these patients.
Detailed Description
About 120cc of blood are collected from the iliac bone marrow under epidural anesthesia.In the cell therapy lab this blood is harvested and mononuclear cells are separated.This procedure takes roughly 4 hours.After dilution the mononuclear cells are injected into the cardiac muscles with fibroses area through 20 shots.This procedure is indicated for patients with cardiac ischemia and left ventricular dysfunction(desynchrony), on whom all the others known therapies have failed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Cardiac Resynchronization, Dilated Cardiomyopathy, Stem Cells Therapy, Heart Failure, Stem Cells/Cardiac Pacing, Artificial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Pacing and Stem Cells Implantations.
Intervention Description
Implantation of Cardiac Ressyncrhonization combined with the implantation of Stem Cells Hematopoietics.
Intervention Type
Procedure
Intervention Name(s)
Pacing and Stem Cells Implantation
Intervention Description
Pacing and Stem Cells Implantation.
Primary Outcome Measure Information:
Title
Ejection Fraction(EF)-(Eco- Sympson):It is the comparison of these measurements between late pre and post operative. NYHA: Comparison of these measurements between late pre and post operative.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Ejection Fraction (Echo/Sympson) and functional class(NYHA).
Time Frame
24 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Dilated Cardiomyopathy
Heart Failure
Optimized Therapeutics
Ventricular Desynchrony
Functional Class III or IV
Ejection Fraction(Echo/ Sympson) < 35%
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Oswaldo Tadeu Greco, PhD
Phone
55-17-3203-4000
Ext
4038
Email
oswaldogreco@terra.com.br
First Name & Middle Initial & Last Name or Official Title & Degree
Ana Carolina de Abreu, MD
Phone
55-17-7811-8477
Email
carolina.cpc@terra.com.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oswaldo Tadeu Greco, PhD
Organizational Affiliation
IMC - Institute of Hearth Diseases
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Oswaldo Tadeu Greco, PhD
Organizational Affiliation
IMC- Institute of Hearth Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imc - Instituto de Moléstias Cardiovasculares
City
São José do Rio Preto
State/Province
São Paulo
ZIP/Postal Code
15015-210
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oswaldo Tadeu Greco, PhD
Phone
55-17-3203-4000
Ext
4038
Email
oswaldogreco@terra.com.br
First Name & Middle Initial & Last Name & Degree
Oswaldo Tadeu Greco, PhD
12. IPD Sharing Statement
Citations:
PubMed Identifier
17874006
Citation
Jacob JL, Salis FV, Ruiz MA, Greco OT. Labeled stem cells transplantation to the myocardium of a patient with Chagas' disease. Arq Bras Cardiol. 2007 Aug;89(2):e10-1. doi: 10.1590/s0066-782x2007001400014. English, Portuguese.
Results Reference
result
Links:
URL
http://deca.org.br
Description
Departamento de Estimulação Cardiaca e Arritmia.
URL
http://imconline.com.br
Description
IMC-Instituto de Moléstias Cardiovasculares
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Stem Cells and Resynchronization Cardiac
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