Autologous Hematopoietic Stem Cell Transplantation for Refractory Lupus Nephritis
Condition: Lupus Nephritis
MeSH terms: Nephritis; Lupus Nephritis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Autologous hematopoietic stem cell transplantation
Intervention type(s): Procedure
Intervention description(s): Stem cell mobilization and collection: 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 .
Conditioning and reinfusion of stem cells: 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment