Implantation of Peripheral Stem Cells in Patient With Ischemic Cardiomyopathy
NCT ID: NCT01615250
Last Updated: 2012-06-11
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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UNKNOWN
PHASE1
50 participants
INTERVENTIONAL
2012-01-31
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Standard therapy
Treatment with standard therapy. Cardiospec shock-wave therapy
No interventions assigned to this group
Stem cells
Group of of intramyocardial implantation of peripheral mononuclear cells with CD34+ stem cells in patient with ischemic cardiomyopathy after preparatory course of shock - wave therapy.
Intramyocardial implantation of stem cells
Intramyocardial implantation of autologous peripheral mononuclear cells with CD34+ stem cells by NOGA.XP navigation system. Сell concentration is 200 million cells in 1 ml.
Interventions
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Intramyocardial implantation of stem cells
Intramyocardial implantation of autologous peripheral mononuclear cells with CD34+ stem cells by NOGA.XP navigation system. Сell concentration is 200 million cells in 1 ml.
Eligibility Criteria
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Inclusion Criteria
* MI more than 6 months before the study
* LVEF less than 35%
* Absence effect of coronary revascularization during 6 months
* 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
* Active oncology desiase
* Pregnancy
20 Years
75 Years
ALL
No
Sponsors
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Odessa National Medical University
OTHER
Responsible Party
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Iurii Kozlov
Dr., PhD Iurii I Karpenko
Principal Investigators
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Iurii I Karpenko, Dr, PhD
Role: PRINCIPAL_INVESTIGATOR
Odessa National Medical University
Locations
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Odessa Regional Clinical Hospital
Odesa, , Ukraine
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ISCIC-2012
Identifier Type: -
Identifier Source: org_study_id
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