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This is a randomized study of efficiency and safety of intramyocardial implantation of peripheral mononuclear cells with high concentration of CD34+ stem cells in patients with myocardial ischemia after preparatory course of shock - wave therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard therapy | No Intervention | Treatment with standard therapy. Cardiospec shock-wave therapy | |
| Stem cells | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intramyocardial implantation of stem cells | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in global left ventricular ejection fraction and regional wall motion score index | Change in global left ventricular ejection fraction and regional wall motion score index. | 6 and12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of the major adverse cardiac events | Incidence of the major adverse cardiac events. | 6 and 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Iurii I Karpenko, Dr, PhD | Contact | +38048750113 | +38048750113 | arcard2@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Iurii I Karpenko, Dr, PhD | Odessa National Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odessa Regional Clinical Hospital | Recruiting | Odesa | 65025 | Ukraine |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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