Status:

UNKNOWN

Treatment of Systemic Sclerosis With Autologous Regulatory Т-cells

Lead Sponsor:

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

Collaborating Sponsors:

Belarusian State Medical University

Conditions:

Systemic Sclerosis

Eligibility:

All Genders

18-80 years

Phase:

PHASE1

PHASE2

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 ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

September 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2023

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT05214014

Start Date

September 1 2022

End Date

December 31 2023

Last Update

September 14 2022

Active Locations (1)

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1

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

Minsk, Belarus, 220072