Systemic Lupus Erythematosus
Conditions
Keywords
Systemic Lupus Erythematosus, mesenchymal stem cells
Brief summary
Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells
Interventions
BIOLOGICALPooled mesenchymal stem cell
Pooled allogenic mesenchymal stem cell derived from olfactory mucosa
Standard SLE treatment according to the Clinical protocols approved by the Ministry of healthcare of Republic of Belarus
Sponsors
Belarusian State Medical University
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy evaluation | 6 month | Efficacy evaluation (SELENA-SLEDAI) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety eveluation | 1 month | Absence of adverse reactions |
Countries
Belarus
Outcome results
None listed