Treatment of Systemic Sclerosis With Autologous Regulatory Т-cells

Study Overview
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Brief Summary
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Treatment of patients with systemic sclerosis with autologous regulatory Т-cells

Detailed Description
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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.

Official Title
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Treatment of Patients With Systemic Sclerosis With Autologous Regulatory Т-cells

Conditions
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Systemic Sclerosis

Intervention / Treatment
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* Biological: Autologous Regulatory Т-cells
* Other: Standard treatment according to the clinical protocols


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of Systemic Sclerosis The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation Written informed consent Exclusion Criteria: The presence of any malignant tumor within the last 5 years Acute or chronic diseases in the stage of decompensation Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol Patients are unable or unwilling to give written informed consent and / or follow research procedures Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells<br>Group 1: Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells | Biological: Autologous Regulatory Т-cells<br>* 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<br>Other: Standard treatment according to the clinical protocols<br>* Standard treatment of Systemic Sclerosis according to the clinical protocols<br>|
| Active Comparator: Patients with multiple sclerosis receiving standard treatment<br>Group 2: Patients with multiple sclerosis receiving standard treatment | Other: Standard treatment according to the clinical protocols<br>* Standard treatment of Systemic Sclerosis according to the clinical protocols<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |