Human Umbilical Cord Mesenchymal Stem Cells Treatment for Lupus Nephritis (LN)

• Status: Unknown status
• Trial end date: 2021-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Lupus nephritis (LN) is one of the most serious complications and the main cause of death in patients with systemic lupus erythematosus (SLE).The investigators have investigated the usefulness, and confirmed the efficacy and safety of mesenchymal stem cells (MSC) treatment of LN in animal models, in vitro experiments and phase I clinical trial. In this study, a randomized, placebo-controlled, parallel group, non-inferiority, prospective, multicenter clinical trial is performed to investigate the efficacy and safety of MSC transplantation in the treatment of LN compared to mycophenolate mofetil (MMF).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Lingyun Sun
• Treatments: Mycophenolic Acid

Criteria

Inclusion Criteria:

1. Subjects who met the American college of Rheumatology (ACR, 1997) classification criteria for SLE;

2. Ages: 18-60 years old (including);

3. 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);

4. Morning proteinuria /creatinine ratio >1.0 or 24 hours Proteinuria >1.0g, with or without microscopic hematuria(>5 red blood cells/high-power field);

5. Women of childbearing age agreed to adopt effective contraception measures during the trial period;

6. Urine pregnancy tests were negative in women of childbearing age;

7. Subject signed the informed consent form voluntarily and complied with the requirements of the research program.

Exclusion Criteria:

1. Received MMF, CTX, other potent immunosuppressive agents (including cyclosporine, tacrolimus, Tripterygium wilfordii and leflunomide) or biologics (Rituximab or others) within the past 12 weeks.

2. Previous failure to respond to MMF.

3. Known intolerance to MMF.

4. Renal biopsy showing ≥50% glomerulus sclerosis.

5. Renal biopsy showing capillary loops necrosis, microthrombus formation in capillary loops, or cellular crescent in ≥50% of glomeruli.

6. 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.

7. 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).

8. Patients with hematological abnormalities (white blood cell <3000/uL, hemoglobin <8g/dL, and/or platelets <50000/uL).

9. 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.

10. 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.

11. History of malignancy, including solid tumor and hematologic malignancies (except basal cell carcinoma which has been excised or successfully treated).

12. Women who are pregnant or breastfeeding.