Systemic Lupus ErythematosusPhase 1/2NCT04184258
Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells
A Phase 1/2 study testing Pooled mesenchymal stem cell and Standard treatment according to the Clinical protocols in people with Systemic Lupus Erythematosus, run by Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus at 1 site in Belarus.
Trial summary
Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Pooled mesenchymal stem cell and Standard treatment according to the Clinical protocols
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jul 2019to 31 Dec 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SLE diagnosis (4 of 11 criteria by ACR);
- positive dsDNA;
- SELENA-SLEDAI index ≥6;
- active lupus nephritis;
- patient can read, understand and follow the procedures.
Who cannot join
- need for dialysis;
- planned renal transplantation;
- any medical condition which can be associated with the high risk for the patient;
- pregnancy/lactation;
- chronic infections, including hepatitis B/C, tuberculosis, HIV;
- any malignant tumor in the last 5 years.
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 Systemic Lupus Erythematosus With Pooled Allogenic Olfactory Mucosa Derived Mesenchymal Stem Cells
Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Pooled mesenchymal stem cell, Standard treatment according to the Clinical protocols
- Keywords
- Systemic Lupus Erythematosus, mesenchymal stem cells
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pooled mesenchymal stem cellBiological
Pooled allogenic mesenchymal stem cell derived from olfactory mucosa
Standard treatment according to the Clinical protocolsOther
Standard SLE treatment according to the Clinical protocols approved by the Ministry of healthcare of Republic of Belarus
| Study group | Role | What they receive |
|---|---|---|
| SLE patients MSC treatment | Experimental | Patients with SLE, who receive pooled mesenchymal stem cells in addition to the standard treatment according to the Clinical protocols Receives: Biological: Pooled mesenchymal stem cell; Other: Standard treatment according to the Clinical protocols |
| SLE patients standard treatment | Active comparator | Patients with SLE, who receive standard treatment according to the Clinical protocols 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.
Efficacy evaluation
Efficacy evaluation (SELENA-SLEDAI)
Measured: 6 month
Secondary outcomes (1)
Safety eveluation
Absence of adverse reactions
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start1 Jul 2019
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- 7 participants (actual)
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, Director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusKonstantin A Chizh, Dr, Study director, Associate professor, Belarusian State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184258
- Sponsor's protocol ID
- IBCE_MSC1(SLE)
- Status last verified
- Jan 2021
- First submitted
- 1 Dec 2019
- Last updated
- 22 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Olfactory Mucosa Derived Mesenchymal Stem Cells
- ClinicalTrials.gov ID
- NCT04184258
- Acronym / sponsor ID
- IBCE_MSC1(SLE)
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, mesenchymal stem cells
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of BelarusOther government
- Collaborators
- Belarusian State Medical University
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 3 Dec 2019 (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 systemic lupus erythematosus with pooled allogenic mesenchymal stem cells
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SLE patients MSC treatment | Experimental | Biological: Pooled mesenchymal stem cell, Other: Standard treatment according to the Clinical protocolsPatients with SLE, who receive pooled mesenchymal stem cells in addition to the standard treatment according to the Clinical protocols |
| SLE patients standard treatment | Active comparator | Other: Standard treatment according to the Clinical protocolsPatients with SLE, who receive standard treatment according to the Clinical protocols |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- SLE diagnosis (4 of 11 criteria by ACR);
- positive dsDNA;
- SELENA-SLEDAI index ≥6;
- active lupus nephritis;
- patient can read, understand and follow the procedures.
Key exclusion criteria (6 listed)
- need for dialysis;
- planned renal transplantation;
- any medical condition which can be associated with the high risk for the patient;
- pregnancy/lactation;
- chronic infections, including hepatitis B/C, tuberculosis, HIV;
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 |
|---|---|---|
| Pooled mesenchymal stem cellPooled allogenic mesenchymal stem cell derived from olfactory mucosa | Biological | SLE patients MSC treatment |
| Standard treatment according to the Clinical protocolsStandard SLE treatment according to the Clinical protocols approved by the Ministry of healthcare of Republic of Belarus | Other | SLE patients MSC treatment, SLE patients standard treatment |
Primary outcome
Efficacy evaluation
Time frame: 6 month
Efficacy evaluation (SELENA-SLEDAI)
1 secondary outcome
Safety eveluation
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
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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
Director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Konstantin A Chizh, Dr study director
Associate professor, 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 Pooled mesenchymal stem cell and Standard treatment according to the Clinical protocols in people with Systemic Lupus Erythematosus, 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 5 inclusion and 6 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: finished, as of the sponsor's last update on 22 Jan 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Efficacy evaluation (time frame: 6 month). 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 22 Jan 2021.