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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01748383
Other study ID # 99
Secondary ID
Status Unknown status
Phase Phase 2
First received December 7, 2012
Last updated December 13, 2012
Start date September 2005
Est. completion date September 2014

Study information

Verified date December 2012
Source Russian Academy of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to test the hypothesis that the intracoronary transplantation of autologous mononuclear and CD 133 + bone marrow cells will improve left ventricular contractile function and will reduce the combined end points after the primary STEMI (mortality, recurrent myocardial infarction, angina, heart failure, stroke).


Description:

The study was randomized, opened, controlled. 85 patients with the first STEMI were enrolled. Patients were divided to three groups. On admission all patients were received thrombolytic therapy by 1,5 million U streptokinase. Transplantation of autologous mononuclear bone marrow cells (BMMCs) and аutologous CD133 + cells by balloon catheter placed into infarct-related artery (IRA) was performed at once after stent implantation in 28 patients patients (1st group) and in 10 patients (2nd group) on the 7-21 days of STEMI. Another 47 patients (3nd group) undergo only stent implantation into IRA the same day of STEMI.

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.


Recruitment information / eligibility

Status Unknown status
Enrollment 85
Est. completion date September 2014
Est. primary completion date September 2013
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria:

- 18 years and to 75 Years

- 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:

- Atrial fibrillation, a permanent form Valvular heart disease

- Severe comorbidity

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
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

Locations

Country Name City State
Russian Federation Scientific and Research Institution of Cardiology of Siberian Department of RAMS Tomsk

Sponsors (1)

Lead Sponsor Collaborator
Russian Academy of Medical Sciences

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Left ventricular ejection fraction (Echo) for an average of 7 years
Secondary incidence of cardiovascular death 7 years
Secondary incidence of the recurrent myocardial infarction 7 years
Secondary incidence of the angina 7 years
Secondary incidence of the heart failure 7 years
Secondary incidence of the stroke 7 years
Secondary incidence of the combined endpoint 7 years
Secondary incidence and severity of adverse events 7 years
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