Umbilical cord mesenchymal stem cells(MSCs) vs IL-2
An acquired deficiency of the cytokine interleukin-2 (IL-2) and associated disturbances in regulatory T cell (Treg) homeostasis play a crucial role in the pathogenesis of systemic lupus erythematosus (SLE). Therefore, expansion of the Treg population by low-dose IL-2 therapy could be effective in reducing disease activity in patients with active and refractory SLE.
Similarly, allogeneic MSC transplantation has shown significant efficacy and good safety in the treatment of refractory autoimmune diseases such as lupus nephritis (LN), and one of its mechanisms is that MSCs up-regulates the production of IL-2 and promotes the production of Treg cells.
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How is Umbilical cord mesenchymal stem cells (MSCs) and IL-2 being studied in Lupus nephritis?
The efficacy and safety of Human Umbilical Cord Mesenchymal Stem Cells and Low-dose IL-2 in the treatment of Lupus Nephritis is being studied in this prospective, single-center, randomized parallel assignment study.
One group of subjects will receive intravenous injection of human umbilical cord mesenchymal stem cells (2 × 106 cells/kg body weight, suspended in 30ml of normal saline); the other group will receive IL-2 (1 × 106 IU) every other day. Subcutaneous injection for 2 weeks (a total of 7 injections), with an interval of 2 weeks, such that 4 weeks is a cycle, and three consecutive cycles of treatment for a total of 12 weeks.
The primary outcome is the response rates in both groups.
Eligibility Criteria
Aged 18-65 years
SLEDAI-2K score ≥ 6
Urinary total protein / creatinine ratio > 1.0 or 24-hour urinary protein > 1.0g, with or without microscopic hematuria