Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells
NCT ID: NCT04184258
Last Updated: 2021-01-22
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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COMPLETED
PHASE1/PHASE2
7 participants
INTERVENTIONAL
2019-07-01
2020-12-31
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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SLE patients MSC treatment
Patients with SLE, who receive pooled mesenchymal stem cells in addition to the standard treatment according to the Clinical protocols
Pooled mesenchymal stem cell
Pooled allogenic mesenchymal stem cell derived from olfactory mucosa
Standard treatment according to the Clinical protocols
Standard SLE treatment according to the Clinical protocols approved by the Ministry of healthcare of Republic of Belarus
SLE patients standard treatment
Patients with SLE, who receive standard treatment according to the Clinical protocols
Standard treatment according to the Clinical protocols
Standard SLE treatment according to the Clinical protocols approved by the Ministry of healthcare of Republic of Belarus
Interventions
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Pooled mesenchymal stem cell
Pooled allogenic mesenchymal stem cell derived from olfactory mucosa
Standard treatment according to the Clinical protocols
Standard SLE treatment according to the Clinical protocols approved by the Ministry of healthcare of Republic of Belarus
Eligibility Criteria
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Inclusion Criteria
* positive dsDNA;
* SELENA-SLEDAI index ≥6;
* active lupus nephritis;
* patient can read, understand and follow the procedures.
Exclusion Criteria
* 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.
18 Years
75 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
Director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Konstantin A Chizh, Dr
Role: STUDY_DIRECTOR
Associate professor, 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_MSC1(SLE)
Identifier Type: -
Identifier Source: org_study_id
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