NCT05214014

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 29, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

1.3 years

First QC Date

November 29, 2021

Last Update Submit

September 9, 2022

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

Study Arms (2)

Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells

EXPERIMENTAL

Group 1: Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells

Biological: Autologous Regulatory Т-cellsOther: Standard treatment according to the clinical protocols

Patients with multiple sclerosis receiving standard treatment

ACTIVE COMPARATOR

Group 2: Patients with multiple sclerosis receiving standard treatment

Other: Standard treatment according to the clinical protocols

Interventions

Autologous Regulatory Т-cellsBIOLOGICAL

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

Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells
Standard treatment according to the clinical protocolsOTHER

Standard treatment of Systemic Sclerosis according to the clinical protocols

Patients with multiple sclerosis receiving standard treatmentPatients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Systemic Sclerosis
  • The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
  • Written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Minsk, 220072, Belarus

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Andrei Hancharou, Dr

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

    STUDY DIRECTOR

  • Kanstantsin Chyzh, Dr

    Belarusian State Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 29, 2021

First Posted

January 28, 2022

Study Start

September 1, 2022

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

September 14, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)