Treatment of Systemic Sclerosis With Autologous Regulatory Т-cells

Systemic Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05214014
• Other study ID #: IBCE_TREGS
• Status: Enrolling by invitation
• Phase: Phase 1/Phase 2
• Start date: September 1, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2022
• Source: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Systemic
• Sclerosis
• Systemic Sclerosis

Intervention

Biological:
• Autologous Regulatory ?-cells
Autologous Regulatory ?-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

Locations

Country	Name	City	State
Belarus	Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus	Minsk

Sponsors (2)

Lead Sponsor	Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus	Belarusian State Medical University

Country where clinical trial is conducted

Belarus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR/EULAR systemic sclerosis criteria	?alculation of ACR/EULAR systemic sclerosis criteria score	6 month
Primary	ACR/EULAR systemic sclerosis criteria	?alculation of ACR/EULAR systemic sclerosis criteria score	1 year
Primary	Adverse effects associated with the therapy	Determination of adverse effects associated with the therapy	1 month
Primary	Adverse effects associated with the therapy	Determination of adverse effects associated with the therapy	1 year