Autologous Hematopoietic Stem Cell Transplantation for Refractory Lupus Nephritis
Autologous Hematopoietic Stem Cell Transplantation for Refractory Lupus Nephritis
In this study, we aimed to evaluate the long term efficacy, remission, survival and safety of
 autologous hematopoietic stem cell transplantation in patients with refractory lupus
 nephritis.

 This is an single arm, non-randomized study. Patients who were diagnosed with relapsed and
 refractory lupus nephritis would included in this study. Refractory lupus nephritis is
 defined as no response to at least one type of immunosuppressant therapy (including
 corticosteroids, cyclophosphamide, tacrolimus, mycophenolate mofetil and cyclosporine) for
 more than six months, or relapse during the period maintenance therapy with kidney
 pathological transformation or persistently positive antibodies. Close observation was
 carried out at stem cell harvest, at transplantation, at 3, 6, 12, 18, and 24 months and then
 once a year after autologous stem cell transplantation.

 20-30 cases will be included in this study.
Treatment plan: Peripheral blood stem cells were mobilized with cyclophosphamide (2.0 g/m2)
 for 2 days and granulocyte colony-stimulating factor (G-CSF) at 5-10 μg/kg per day was
 administered when the level of peripheral leucocytes was < 1×109/L. Peripheral leukocyte
 counts were monitored, and harvesting was performed when the peripheral white blood cell
 level rebounded (usually 11 days after cyclophosphamide). The target acquisition was CD34+
 cells > 2×10^6/kg and mononuclear cells > 2×10^8/kg. The graft was preserved at a temperature
 of -196 ℃ for further use. The conditioning regimen consisted of intravenous cyclophosphamide
 (40 mg/kg/day × 4 days) 5 days before transplantation (a total dose 160 mg/kg) and rabbit
 antithymocyte globulin (ATG) (2.5mg/kg/day × 3 days) 4 days before transplantation. The dose
 of cyclophosphamide and ATG could be reduced according to the patients' condition.
 Methylprednisolone (80-500 mg/day) was administered through intravenous drip at the same time
 with ATG to reduce anaphylaxis. The incidence of drug-related complications was decreased by
 hyperhydration (the volume of infusion liquid is 50 ml/kg/day), urine alkalization (infusion
 of sodium bicarbonate 250ml/day), and anti-emetic medication. G-CSF (0.5 μg/kg/d) was
 administered to each patient beginning the day after stem cells reinfusion until the level of
 absolute peripheral neutrophil count was consecutively higher than 1.0 × 10^9/L.
Inclusion Criteria:

 -  1. Diagnosed with relapsed and refractory lupus nephritis; 2. Ages from 14 - 45 years
 old; 3. Serum creatinine < 2mg/dl; 4. Alanine aminotransferase < 2 times of normal
 upper limit; 5. Left ventricular ejection fraction > 50%; 6. Subjects (or their legal
 representatives) must signed an informed consent document.

 Exclusion Criteria:

 -  1. Active infection; 2. Known or suspected hypersensitivity to CTX or ATG; 3. Subjects
 suffering from uncontrolled or severe cardiovascular disease; 4. Subjects suffering
 from serious physical disease and mental illnesses.