Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Randomized, Double Blind, Parallel Group, Placebo Controlled Research of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis
Brief Summary: 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.


Options:
A: Inclusion Criteria:

* Systemic Lupus Erythematosus (SLE) as defined by meeting at least 4 of the 11 classification criteria of the American College of Rheumatology for the classification of Systemic Lupus Erythematosus, either sequentially or coincident. The 4 criteria need not be present at study entry
* Renal biopsy within 12 months prior to screening visit indicating active proliferative lupus glomerulonephritis (met ISN/RPS Class III or IV classification criteria \[2003\], excluding Class III \[C\], IV-S \[C\] and IV-G \[C\], or the World Health Organization Class III or IV classification criteria \[1982\], excluding Class IIIc, IVd). If the renal biopsy was performed \>3 months but ≤12 months prior to screening visit, at least 1 of the following 3 serologies (performed locally) must have been abnormal prior to screening visit: complement (C3 or C4) level below normal range OR anti-dsDNA \>upper limit of normal range.
* A stable serum creatinine ≤3 mg/dL

Exclusion Criteria:

* Subjects with a rise in serum creatinine of ≥1 mg/dL within 1 month prior to the screening visit
* Subjects with drug-induced SLE, as opposed to idiopathic SLE
* Subjects with severe, unstable and/or progressive Central nervous system (CNS) lupus
* Subjects with autoimmune disease other than SLE as their main diagnosis (e.g.; Rheumatoid arthritis (RA), Multiple Sclerosis \[MS\])
* Subjects who have received treatment with cyclophosphamide within 3 months of randomization (Day 1).
* Subjects who have received treatment with rituximab \< 6 months prior to the screening visit
B: Inclusion Criteria:

1. Written informed consent by subject or guardian
2. 18 to 65 years of age (inclusive 18 and 65), male or female
3. Diagnosis of SLE according to the American College of Rheumatology criteria (1997)
4. Diagnosis of Class Ⅲ,Ⅳ,Ⅴ,Ⅲ+Ⅴand Ⅳ+ⅤLN according to the ISN/RPS 2003 classification by light, immunofluorescence, and electron microscopy within 6 months before enrollment
5. Pathologic chronic index (CI) ≤3' without thrombotic microangiopathy (TMA)
6. SLE Disease Activity Index (DAI) \>10'
7. Proteinuria ≥1.5g/d，with or without active urinary sediment
8. Serum creatinine (Scr)≤3.0mg/dl (265.2 mol/L)

Exclusion Criteria:

1. Previous treatment with MMF, CTX, tacrolimus, Cyclosporin A (CsA), large doses of immunoglobulin and methylprednisolone (MP), plasmapheresis or renal replacement therapy within the past 12 weeks. Oral glucocorticoids, azathioprine, intravenous MP (≤80mg/d)， short-time CsA (\<2 weeks) or leflunomide (\<4 weeks) are allowed
2. ALT or AST increase twice above the upper limit of the normal range
3. Hyperglycemia is defined as fasting blood glucose level ≥7.0 mmol/L and/or postprandial blood sugar level\>11.1 mmol/L
4. Known hypersensitivity or contraindication to any components of MMF, tacrolimus, CTX or glucocorticoids
5. History of present illness:

   1. active HBV infection (HBsAg, HBeAg and anti-HBc positive or HBsAg, anti- HBe and anti-HBc positive), HCV infection, pulmonary tuberculosis, cytomegalovirus(CMV) infection (defined as CMV-IgM positive or CMV-DNA positive), fungal infection or HIV infection, within 3 months before the enrollment
   2. non-healed active peptic ulcer within 3 months before the enrollment
   3. drug or drinking abuse
   4. malnutrition (BMI \<18.5kg/m2) or body weight \<50Kg
6. Other active diseases, such as:

   1. severe cardiovascular diseases
   2. chronic obstructive pulmonary disease(COPD)or asthma requiring oral glucocorticoids
   3. marrow depression not due to SLE activation: white blood cell count \<3000/mm3 or neutrophil count \<1300/mm3 or platelet count \<50000/mm3
7. Severe infection or need of antibiotic therapy
8. Female patients who are pregnant/breastfeeding or those patients (both gender) who refused contraception
9. Life-threatening complications such as large hydropericardium, pneumohemorrhagia, lupus encephalopathy and severe pulmonary hypertension or patients in need of MP pulse (\>0.5g/d ) treatment because of aggravation of SLE
10. Known to be non-compliance or violation of the protocol base on investigator's judgement
11. Patient who participate of any other investigational drug study.
C: Inclusion Criteria:

* male or female patients, 12-75 years of age;
* diagnosis of systemic lupus erythematosus;
* kidney biopsy within 6 months of study, with histological diagnosis of lupus nephritis;
* laboratory evidence of active nephritis.

Exclusion Criteria:

* continuous dialysis starting \>2 weeks before randomization into induction phase, and/or with an anticipated duration of \>8 weeks;
* previous or planned kidney transplant;
* other clinically significant active medical conditions.
D: 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

Exclusion Criteria:

Patients with any of the following are not eligible for enrollment into the study:

1. Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test.
2. Participation in any research in which the patient received an investigational product within 30 days preceding the screening phase of this study.
3. Those persons directly involved in the conduct of the study.
4. Serum creatinine more than 250 µmol/L.
5. White blood cell (WBC) count of less than 3.5 X 109/L.
6. Active peptic ulcer disease.
7. Active systemic infection.
8. History of alcohol or substance abuse.
9. History of malignancy within previous 5 years.
10. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study.

Answer: D