The Long-term and Short-term Efficacy and Safety of Transplantation Autologous Bone Marrow Cells (BMCs) in Patients With the First STEMI (ST Segment Elevation Myocardial Infarction)
NCT ID: NCT01748383
Last Updated: 2012-12-17
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
PHASE2
85 participants
INTERVENTIONAL
2005-09-30
2014-09-30
Brief Summary
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Detailed Description
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Autologous BMMCs were obtained from bone marrow aspirate by gradient centrifugation. Echocardiography, Holter monitoring were performed. Plasma concentration of the pro-inflammatory and anti-inflammatory cytokines (IL1, 6,8,10), of the growth factors (stem cell factor - SCF, vascular endothelial growth factor - VEGF, hepatocyte growth factor - HGF, fibroblast growth factor - FGF, insulin-like growth factor - IGF), the number of circulating CD34 +38-, CD133 +, СD117 +, CD90 +34- stem cells were determined in these patients in the acute and sub-acute myocardial infarction period.
It is going 7 years after the beginning of planned to evaluate left ventricular function of these patients, incidence of cardiovascular end points (death, recurrent myocardial infarction, angina, heart failure, stroke) and their combinations, to evaluate the safety of transplantation of autologous BMCs (formation of intra-myocardial tumor or neoplastic processes of other sites) after 7 years from the beginning of study.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Transplantation of BMMCs
Autologous BMCs aspiration and transplantation of these cells
Transplantation of BMMCs
The wing of the ilium was punctured under the local anesthesia for receiving of autologous BMCs. 100 ml of bone marrow aspirate was taken. BMMCs were obtained by the method of the gradient centrifugation. Autologous BMMCs in the number 93±43 million transplantation by balloon catheter performed into IRA at once after stent implantation.
Transplantation of CD 133+ cells
Autologous CD 133+ BMCs aspiration and transplantation of CD 133+ cells
Transplantation of CD 133+ cells
The wing of the ilium was punctured under the local anesthesia for receiving of autologous BMCs. 100 ml of bone marrow aspirate was taken. Autologous CD133 + cells were obtained by the method of the magnetic separation. Phenotyping of the transplanted cells was performed by the cytofluorimetry. Autologous CD 133+ BMCs in the number 5,7 (0,45;9,0) million transplantation by balloon catheter performed into IRA at once after stent implantation.
stenting of IRA
The only stenting of IRA
stenting of IRA
The only stent implantation
Interventions
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Transplantation of BMMCs
The wing of the ilium was punctured under the local anesthesia for receiving of autologous BMCs. 100 ml of bone marrow aspirate was taken. BMMCs were obtained by the method of the gradient centrifugation. Autologous BMMCs in the number 93±43 million transplantation by balloon catheter performed into IRA at once after stent implantation.
Transplantation of CD 133+ cells
The wing of the ilium was punctured under the local anesthesia for receiving of autologous BMCs. 100 ml of bone marrow aspirate was taken. Autologous CD133 + cells were obtained by the method of the magnetic separation. Phenotyping of the transplanted cells was performed by the cytofluorimetry. Autologous CD 133+ BMCs in the number 5,7 (0,45;9,0) million transplantation by balloon catheter performed into IRA at once after stent implantation.
stenting of IRA
The only stent implantation
Eligibility Criteria
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Inclusion Criteria
* Informed consent
* First STEMI
* Term admission to an intensive care unit in the first 24 hours of onset
* Time reperfusion of the IRA is not earlier than 4 hours after the initial onset of acute transmural myocardial infarction
Exclusion Criteria
* Severe comorbidity
18 Years
75 Years
ALL
No
Sponsors
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Russian Academy of Medical Sciences
OTHER
Responsible Party
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Vyacheslav Ryabov
Leading researcher of Emergency Cardiology Department
Principal Investigators
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Vyacheslav Ryabov, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Scientific and Research Institution of Cardiology of Siberian Department of RAMS
Locations
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Scientific and Research Institution of Cardiology of Siberian Department of RAMS
Tomsk, , Russia
Countries
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Other Identifiers
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99
Identifier Type: -
Identifier Source: org_study_id