Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells

Phase 2CompletedNCT04184258

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus7 enrolled

Overview

Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Systemic Lupus Erythematosus

Interventions

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Minsk, Belarus

Outcomes

Primary Outcomes

Efficacy evaluation

Efficacy evaluation (SELENA-SLEDAI)

Time frame: 6 month

Secondary Outcomes

Safety eveluation

Absence of adverse reactions

Time frame: 1 month

Data from ClinicalTrials.gov

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