Treatment of Systemic Sclerosis With Autologous Regulatory Т-cells
NCT ID: NCT05214014
Last Updated: 2022-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
30 participants
INTERVENTIONAL
2022-09-01
2023-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
Standard treatment according to the clinical protocols
Standard treatment of Systemic Sclerosis according to the clinical protocols
Patients with multiple sclerosis receiving standard treatment
Group 2: Patients with multiple sclerosis receiving standard treatment
Standard treatment according to the clinical protocols
Standard treatment of Systemic Sclerosis according to the clinical protocols
Interventions
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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
Standard treatment according to the clinical protocols
Standard treatment of Systemic Sclerosis according to the clinical protocols
Eligibility Criteria
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Inclusion Criteria
* The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
* Written informed consent
Exclusion Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
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Belarusian State Medical University
OTHER
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
OTHER_GOV
Responsible Party
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Principal Investigators
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Andrei Hancharou, Dr
Role: STUDY_DIRECTOR
the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Kanstantsin Chyzh, Dr
Role: STUDY_DIRECTOR
Belarusian State Medical University
Locations
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Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, , Belarus
Countries
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Other Identifiers
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IBCE_TREGS
Identifier Type: -
Identifier Source: org_study_id
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