Intramyocardial Multiple Precision Injection of Bone Marrow Mononuclear Cells in Myocardial Ischemia
NCT ID: NCT01354678
Last Updated: 2020-02-13
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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TERMINATED
PHASE1
15 participants
INTERVENTIONAL
2011-05-31
2019-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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group of bone marrow cell therapy
NOGA XP Cardiac Navigation System
Intramyocardial multiple precision injection of bone marrow mononuclear cells
group of sham therapy
NOGA XP Cardiac Navigation System
Intramyocardial multiple precision injection with placebo
Interventions
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NOGA XP Cardiac Navigation System
Intramyocardial multiple precision injection of bone marrow mononuclear cells
NOGA XP Cardiac Navigation System
Intramyocardial multiple precision injection with placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* MI more than 6 months before the study
* LVEF less than 35%
* absence of indication to coronary revascularization
* optimal pharmacological therapy no less than 8 weeks
* heart transplantation is contraindicated
* patients with implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D)
* patients giving informed consent
Exclusion Criteria
* coronary revascularization less than 6 months
* patients requiring surgical correction of post-MI aneurism
* LV wall thickness less than 5 mm in site of possible injection
* patients with CRT implanted within 3 month before cells injection
* clinically significant associated diseases
18 Years
69 Years
ALL
No
Sponsors
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Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health
OTHER
Responsible Party
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Principal Investigators
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Eugene V Shlyakhto, Prof
Role: PRINCIPAL_INVESTIGATOR
Almazov Federal Heart, Blood and Endocrinology Centre
Locations
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Almazov Federal National Medical Research Centre
Saint Petersburg, , Russia
Countries
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Other Identifiers
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IMPI-1
Identifier Type: -
Identifier Source: org_study_id
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