Treatment of Systemic Sclerosis With Autologous Regulatory Т-cells

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Status and phase: Invitation-only; Phase 2; Phase 1

Conditions: Systemic Sclerosis

Treatments: Biological: Autologous Regulatory Т-cells; Other: Standard treatment according to the clinical protocols

Study type: Interventional

Funder types: Other

Identifiers

NCT05214014

IBCE_TREGS

Details and patient eligibility

About

Treatment of patients with systemic sclerosis with autologous regulatory Т-cells

Full 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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells

Experimental group

Description:

Group 1: Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells

Treatment:

Biological: Autologous Regulatory Т-cells

Other: Standard treatment according to the clinical protocols

Patients with multiple sclerosis receiving standard treatment

Active Comparator group

Description:

Group 2: Patients with multiple sclerosis receiving standard treatment

Treatment:

Other: Standard treatment according to the clinical protocols