Mesenchymal Stem cells (MSE_LE)
Mesenchymal stem cells (MSCs) are derived from bone marrow and are capable of differentiating into a variety of mesenchymal lineages and also possess immune-modulatory capabilities. They have emerged as a potentially beneficial therapy for Lupus nephritis by reducing autoimmune activities through immunomodulatory effects.
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How is MSE_LE being studied in Lupus nephritis?
The safety and efficacy of Mesenchymal Stem Cells (MSV-allo) in achieving a full or partial treatment response of Lupus Nephritis, in patients who do not respond -or respond partially- to induction treatment was studied in this Phase II, Double-Blind, Placebo-Controlled Clinical Trial. The primary outcome is the proportion of patients who have achieved a complete response.
Eligibility Criteria
Aged ≥18 years
Diagnosis of lupus nephritis (LN) using the 2003 classification of the International Society of Nephrology and the Society of Renal Pathology, by biopsy performed no more than 6 months before the selection visit if they enter from the induction period, and no more than one year if they enter with a moderate/severe recurrence.
No response or partial response to standard treatment, or moderate/severe recurrence of lupus nephritis.
SLEDAI-2K ≥ 10 during the selection period.
Women of childbearing potential should use effective methods of contraception to prevent pregnancy.