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| Name | Class |
|---|---|
| Belarusian State Medical University | OTHER |
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Treatment of patients with systemic sclerosis with autologous regulatory Т-cells
Considering the fact that a decrease in the content and functional activity of T-reg plays an important role in the immunopathogenesis of many systemic diseases of the connective tissue, the use of a large amount of T-reg can have a therapeutic effect.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells | Experimental | Group 1: Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells |
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| Patients with multiple sclerosis receiving standard treatment | Active Comparator | Group 2: Patients with multiple sclerosis receiving standard treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous Regulatory Т-cells | Biological | Autologous Regulatory Т-cells obtained from CD4+CD25+ cells isolated from PBMC and cultured with the cocktail of cytokines and antibodies to induce proliferation of Tregs |
| Measure | Description | Time Frame |
|---|---|---|
| ACR/EULAR systemic sclerosis criteria | Сalculation of ACR/EULAR systemic sclerosis criteria score | 6 month |
| ACR/EULAR systemic sclerosis criteria | Сalculation of ACR/EULAR systemic sclerosis criteria score | 1 year |
| Adverse effects associated with the therapy | Determination of adverse effects associated with the therapy | 1 month |
| Adverse effects associated with the therapy | Determination of adverse effects associated with the therapy | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrei Hancharou, Dr | the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus | Study Director |
| Kanstantsin Chyzh, Dr | Belarusian State Medical University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus | Minsk | 220072 | Belarus |
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| ID | Term |
|---|---|
| D012595 | Scleroderma, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
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| Standard treatment according to the clinical protocols | Other | Standard treatment of Systemic Sclerosis according to the clinical protocols |
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