The efficacy measure of hUC-MSC in the treatment of proliferative lupus nephritis on remission of lupus nephritis (combined partial and complete remission) in terms of stabilization and improvement in renal function.
Inclusion criteria: 1. Male or non-pregnant females age 16 to 65 years inclusive. 2. Written informed consent obtained from patient or parents/guardian. 3. Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score\>8 or BILAG score A/B. 4. Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
Human Umbilical Cord derived MSCs treatment for lupus nephritis via infusion
Cyclophosphamide based immunosuppressive agent for treatment for lupus nephritis
Second Affiliated Hospital & SLE Research Centre, Kunming Medical University, Kunming China
Kunming, Yunan, China
RECRUITINGEfficacy and Safety
The efficacy measure is remission of nephritis (combined partial and complete remission) at 6 months defined as * Stabilization or improvement in renal function and * Urinary RBC of less than 10 per HPF and * Reduction of proteinuria to less than 3 g/day if baseline proteinuria was more than 3 g/day and at least a 50% reduction in proteinuria, or to less than 1 g/day if the baseline proteinuria was in the subnephrotic range.
Time frame: 6 months
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