Systemic Lupus Erythematosus
Conditions
Interventions
Case series:allogeneic umbilical cord (UC) derived mesenchymal stem cells (MSCs)
Sponsors
Anhui Provincial Hospital, The First affiliated Hospital of University of Science and Technology of China
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 and 65 years old at the screening visit. 2. SLE diagnosis: According to the American College of Rheumatology classification criteria, 4 or more of the ACR 11 criteria appear continuously or simultaneously during any interval or observation period was clinical diagnosed as SLE; 3. The SELENA-SLEDAI score was not lower than8 points during screening period; 4. Refractory SLE patients: refractory SLE patients refer to the one who are not effective or poor effect (clinical symptoms or signs are not relieved) for the treatment of conventional glucocorticoid and immunosuppressive agents, including the following drugs used alone or in combination: The dose of Prednisone or analogue=20mg/day, The monthly treatment dose of Cyclophosphamide was 500-1000mg/m2 body surface area for more than 6 months, Mycophenolate mofetil 1.5-2g/day, azathioprine 1-2mg/kg/day, leflunomide 20-40mg/day, methotrexate 7.5-15mg/week, cyclosporine A 3-5mg/kg/day for more than 3 months; 5. Syphilis and HIV antibody are negative, no intravenous drug addiction history, 6. Understand the research process, sign the informed consent form, and follow-up on time.
Exclusion criteria
Exclusion criteria: 1. Other uncontrolled diseases: clinically proved significantly unstable or not effectively controlled acute or chronic diseases which have no relation with SLE(ie, cardiovascular, lung, hematology, gastrointestinal, liver, kidney, nervous system, malignant tumor, or infectious disease), may confuse the results of study and or make the subject at an inappropriate risk; 2. Infection: active or recurrent bacterial, viral, fungal, mycobacterial or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, granulomatous disease diagnosed by chest X-ray, hepatitis B and C, HIV infection, syphilis infection, herpes zoster, but does not include a fungal infection; 3. Allergic reaction: may be allergic to the preparation used in the study; 4. Pregnant women or women who are breastfeeding; 5. Subjects with a history of malignant tumors, including solid tumors and hematological malignancies; 6. Those who are participating in other clinical drug trials.
Contacts
Public ContactXiaomei Li
Anhui Provincial Hospital, The first affiliated Hospital of University of Science and Technology of China
Outcome results
None listed