Human Umbilical Cord Mesenchymal Stem Cells Treatment for Lupus Nephritis (LN)
Lupus Nephritis
About this trial
This is an interventional treatment trial for Lupus Nephritis focused on measuring Lupus Nephritis, Mesenchymal stem cell
Eligibility Criteria
Inclusion Criteria:
- Subjects who met the American college of Rheumatology (ACR, 1997) classification criteria for SLE;
- Ages: 18-60 years old (including);
- Presence of class III, IV, V, III+V or IV+V LN as determined by renal biopsy within 12 weeks of randomization(2003 ISN/RPS LN classification criteria);
- Morning proteinuria /creatinine ratio >1.0 or 24 hours Proteinuria >1.0g, with or without microscopic hematuria(>5 red blood cells/high-power field);
- Women of childbearing age agreed to adopt effective contraception measures during the trial period;
- Urine pregnancy tests were negative in women of childbearing age;
- Subject signed the informed consent form voluntarily and complied with the requirements of the research program.
Exclusion Criteria:
- Received MMF, CTX, other potent immunosuppressive agents (including cyclosporine, tacrolimus, Tripterygium wilfordii and leflunomide) or biologics (Rituximab or others) within the past 12 weeks.
- Previous failure to respond to MMF.
- Known intolerance to MMF.
- Renal biopsy showing ≥50% glomerulus sclerosis.
- Renal biopsy showing capillary loops necrosis, microthrombus formation in capillary loops, or cellular crescent in ≥50% of glomeruli.
- Patients diagnosed with other autoimmune diseases apart from SLE: dermatomyositis/polymyositis, mixed connective tissue disease, scleroderma, rheumatoid arthritis, etc. However, participants with secondary Sjogren's syndrome are allowed to take part in the study.
- Patients suffering from severe liver or kidney dysfunction (total bilirubin more than 14mg/L, aspartate aminotransferase (AST) or alanine aminotransferase (ALT) more than 1.5 times the upper limit of normal lab value; creatinine clearance rate (Ccr) < 30ml/min or serum creatinine (Scr) ≥265.2umol/L).
- Patients with hematological abnormalities (white blood cell <3000/uL, hemoglobin <8g/dL, and/or platelets <50000/uL).
- Patients diagnosed with severe or uncontrolled cardiovascular, neurological, pulmonary (including obstructive pulmonary disease and interstitial lung disease), hepatic, endocrine (including uncontrolled diabetes mellitus), and gastrointestinal disorders.
- Known active or history of recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis, atypical mycobacterial infection, granulomatous disease showed by chest X-ray, hepatitis B, hepatitis C, HIV infection and herpes zoster, whereas not including onychomycosis). Any infection requiring hospitalization within 4 weeks prior to enrollment or intravenous antimicrobial treatment within 2 weeks prior to randomization.
- History of malignancy, including solid tumor and hematologic malignancies (except basal cell carcinoma which has been excised or successfully treated).
- Women who are pregnant or breastfeeding.
Sites / Locations
- The Affiliated Drum Tower Hospital of Nanjing University Medical School
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Mesenchymal stem cells
Mycophenolate Mofetil
The group receive pulse infusion of MSCs and placebo of oral Mycophenolate Mofetil (MMF). The cells of 2 x 10^6/kg body weight are suspended in 100ml saline and infused intravenously. Dexamethasone of 10mg is intravenously injected before 30 minutes of cells infusion. A sterile blood transfusion device is used during the venous transfusion, and it is washed with saline before infusion. Take a slow infusion of about 20 drops per minute in the first 15 minutes. Increase to about 60 drops per minute if the patient had no complaints of discomfort.
The group receive placebo of MSCs and oral Mycophenolate Mofetil of 2.0g/d. .