Treatment of Systemic Sclerosis With Autologous Regulatory Т-cells

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

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

Study Overview

• Status: Enrolling by invitation
• Conditions: Systemic Sclerosis
• Intervention / Treatment: Biological: Autologous Regulatory Т-cells; Other: Standard treatment according to the clinical protocols

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Belarus
  • Minsk, Belarus, 220072
    • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
• Collaborators: Belarusian State Medical University
• Investigators: Study Director: Kanstantsin Chyzh, Dr, Belarusian State Medical University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2023

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: January 25, 2022
• First Posted (Actual): January 28, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Skin Diseases; Connective Tissue Diseases; Sclerosis; Scleroderma, Systemic; Scleroderma, Diffuse
• Other Study ID Numbers: IBCE_TREGS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No