Treatment of Systemic Sclerosis With Autologous Regulatory Т-cells

Phase 1

• Conditions: Systemic Sclerosis
• Interventions: Other: Standard treatment according to the clinical protocols; Biological: Autologous Regulatory Т-cells

• Registration Number: NCT05214014
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

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.

Study Timeline

• Study First Submitted: 2021-11-29
• Study First Submitted QC: 2022-01-25
• Study First Posted: 2022-01-28
• Status Verified: 2022-09
• Study Start: 2022-09-01
• Last Update Submitted: 2022-09-09
• Last Update Posted: 2022-09-14
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with multiple sclerosis receiving standard treatment	Standard treatment according to the clinical protocols	Group 2: Patients with multiple sclerosis receiving standard treatment
Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells	Autologous Regulatory Т-cells	Group 1: Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells
Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells	Standard treatment according to the clinical protocols	Group 1: Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells

Primary Outcome Measures

Name	Time	Method
ACR/EULAR systemic sclerosis criteria	1 year	Сalculation of ACR/EULAR systemic sclerosis criteria score
Adverse effects associated with the therapy	1 year	Determination of adverse effects associated with the therapy

Trial Locations

Locations (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus; 🇧🇾 Minsk, Belarus