Systemic Sclerosis
Conditions
Brief summary
Treatment of patients with systemic sclerosis with autologous regulatory Т-cells
Detailed description
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.
Interventions
BIOLOGICALAutologous Regulatory Т-cells
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
Standard treatment of Systemic Sclerosis according to the clinical protocols
Sponsors
Belarusian State Medical University
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| ACR/EULAR systemic sclerosis criteria | 6 month | Сalculation of ACR/EULAR systemic sclerosis criteria score |
| Adverse effects associated with the therapy | 1 month | Determination of adverse effects associated with the therapy |
Countries
Belarus
Outcome results
None listed