Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells

Phase 1

Completed

• Conditions: Systemic Lupus Erythematosus
• Interventions: Other: Standard treatment according to the Clinical protocols; Biological: Pooled mesenchymal stem cell

• Registration Number: NCT04184258
• Lead Sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Brief Summary

Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-01
• Study First Submitted: 2019-12-01
• Study First Submitted QC: 2019-12-01
• Study First Posted: 2019-12-03
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-20
• Last Update Posted: 2021-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SLE patients standard treatment	Standard treatment according to the Clinical protocols	Patients with SLE, who receive standard treatment according to the Clinical protocols
SLE patients MSC treatment	Pooled mesenchymal stem cell	Patients with SLE, who receive pooled mesenchymal stem cells in addition to the standard treatment according to the Clinical protocols
SLE patients MSC treatment	Standard treatment according to the Clinical protocols	Patients with SLE, who receive pooled mesenchymal stem cells in addition to the standard treatment according to the Clinical protocols

Primary Outcome Measures

Name	Time	Method
Efficacy evaluation	6 month	Efficacy evaluation (SELENA-SLEDAI)

Secondary Outcome Measures

Name	Time	Method
Safety eveluation	1 month	Absence of adverse reactions

Trial Locations

Locations (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus; 🇧🇾 Minsk, Belarus