Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells

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

Status and phase: Completed; Phase 2; Phase 1

Conditions: Systemic Lupus Erythematosus

Treatments: Biological: Pooled mesenchymal stem cell; Other: Standard treatment according to the Clinical protocols

Study type: Interventional

Funder types: Other

Identifiers

NCT04184258

IBCE_MSC1(SLE)

Details and patient eligibility

About

Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells

Enrollment: 7 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

SLE patients MSC treatment

Experimental group

Description:

Patients with SLE, who receive pooled mesenchymal stem cells in addition to the standard treatment according to the Clinical protocols

Treatment:

Biological: Pooled mesenchymal stem cell

Other: Standard treatment according to the Clinical protocols

SLE patients standard treatment

Active Comparator group

Description:

Patients with SLE, who receive standard treatment according to the Clinical protocols

Treatment:

Other: Standard treatment according to the Clinical protocols