Systemic SclerosisPhase 1/2NCT05214014
Treatment of Systemic Sclerosis With Autologous Regulatory Т-cells
A Phase 1/2 study testing Autologous Regulatory Т-cells and Standard treatment according to the clinical protocols in people with Systemic Sclerosis, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
Trial summary
Treatment of patients with systemic sclerosis with autologous regulatory Т-cells Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Autologous Regulatory Т-cells and Standard treatment according to the clinical protocols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Sep 2022to 31 Dec 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical diagnosis of Systemic Sclerosis
- The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belarus1 site
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Minsk, 220072
About this study
Official title: Treatment of Patients With Systemic Sclerosis With Autologous Regulatory Т-cells
Treatment of patients with systemic sclerosis with autologous regulatory Т-cells
Read the 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.
- Conditions
- Systemic Sclerosis
- Being tested
- Autologous Regulatory Т-cells, Standard treatment according to the clinical protocols
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
Standard treatment according to the clinical protocolsOther
Standard treatment of Systemic Sclerosis according to the clinical protocols
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Autologous Regulatory Т-cells; Other: 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 Receives: Other: Standard treatment according to the clinical protocols |
What is being measured
The primary outcome is the main question the study is designed to answer.
ACR/EULAR systemic sclerosis criteria
Сalculation of ACR/EULAR systemic sclerosis criteria score
Measured: 6 month
ACR/EULAR systemic sclerosis criteria
Сalculation of ACR/EULAR systemic sclerosis criteria score
Measured: 1 year
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Measured: 1 month
Adverse effects associated with the therapy
Determination of adverse effects associated with the therapy
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2022
- Study start1 Sep 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
- Sponsor type
- Other government
- Collaborators
- Belarusian State Medical University
- Responsible party
- Sponsor
- Investigators
- Andrei Hancharou, Dr, Study director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusKanstantsin Chyzh, Dr, Study director, Belarusian State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05214014
- Sponsor's protocol ID
- IBCE_TREGS
- Status last verified
- Sep 2022
- First submitted
- 29 Nov 2021
- Last updated
- 14 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Patients With Systemic Sclerosis With Autologous Regulatory Т-cells
- ClinicalTrials.gov ID
- NCT05214014
- Acronym / sponsor ID
- IBCE_TREGS
- Conditions
- Systemic Sclerosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
- Collaborators
- Belarusian State Medical University
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 large amount of T-reg can have a therapeutic effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells | Experimental | Biological: Autologous Regulatory Т-cells, Other: Standard treatment according to the clinical protocolsGroup 1: Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells |
| Patients with multiple sclerosis receiving standard treatment | Active comparator | Other: Standard treatment according to the clinical protocolsGroup 2: Patients with multiple sclerosis receiving standard treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of Systemic Sclerosis
- The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
- Written informed consent
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Regulatory Т-cellsAutologous 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 | Biological | Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells |
| Standard treatment according to the clinical protocolsStandard treatment of Systemic Sclerosis according to the clinical protocols | Other | Patients with multiple sclerosis receiving standard treatment, Patients with systemic sclerosis receiving standard treatment and autologous regulatory Т-cells |
Primary outcome
ACR/EULAR systemic sclerosis criteria
Time frame: 6 month
Сalculation of ACR/EULAR systemic sclerosis criteria score
ACR/EULAR systemic sclerosis criteria
Time frame: 1 year
Сalculation of ACR/EULAR systemic sclerosis criteria score
Adverse effects associated with the therapy
Time frame: 1 month
Determination of adverse effects associated with the therapy
Adverse effects associated with the therapy
Time frame: 1 year
Determination of adverse effects associated with the therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrei Hancharou, Dr study director
the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Kanstantsin Chyzh, Dr study director
Belarusian State Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous Regulatory Т-cells and Standard treatment according to the clinical protocols in people with Systemic Sclerosis, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ACR/EULAR systemic sclerosis criteria (time frame: 6 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.