By Pass Surgery With Stem Cell Therapy in Chronic Ischemic Cardiopathy
NCT ID: NCT00690209
Last Updated: 2014-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
12 participants
INTERVENTIONAL
2008-05-31
2013-01-31
Brief Summary
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Recently, a reduction of cardiac volumes and improvement of regional and global contractility has been demonstrated in patients with advanced ischemic heart disease, severe dilation of left ventricle and poor candidates for revascularization after injection of stem cells in territories with residual viability.
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Detailed Description
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Subsequently all patients will be evaluated by cardiac ce-MR and PET imaging for verification of inclusion criteria.
Patients will be allocated in a single blind manner to one of two therapeutic arms: surgical revascularization alone or surgical revascularization associated with autologous bone marrow derived stem cells injection in viable territories.
During the follow up evolution of left ventricular volumes and contractility will be analyzed by ce-MR and PET imaging at 1 year. Additionally patients' functional status will be assessed by metabolic stress tests and quality of life questionnaire at 6 months, 1 year and 2 years.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SINGLE
Interventions
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Autologous bone marrow derived stem cells myocardial transplantation
Eligibility Criteria
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Inclusion Criteria
* Left ventricular dilation (end systolic volume \>140 ml)
* Poor global contractile function (ejection fraction \<40%)
* Substantial amount of residual viability (\>30% of left ventricle)
18 Years
75 Years
ALL
No
Sponsors
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University Hospital, Clermont-Ferrand
OTHER
Responsible Party
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Principal Investigators
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Janusz Lipiecki, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Clermont-Ferrand
Locations
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Departements of CardiacSurgery, Cardiology and Radiology
Clermont-Ferrand, , France
Countries
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Other Identifiers
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CHU-0034
Identifier Type: -
Identifier Source: org_study_id
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