Mesenchymal Stem Cells Transplantation for Refractory Systemic Lupus Erythematosus (SLE)
Mesenchymal Stem Cells Transplantation for Refractory Systemic Lupus Erythematosus (SLE)
This study will explore a new approach to treat patients with a medical condition known as
 systemic lupus erythematosus (SLE) who have been resistant to previous treatments using a new
 population of cells with capability to restore a normal immune system that will no longer
 attack the body.

 The stated hypothesis is that the SLE condition is caused by an abnormal immune system that
 can be restored by replenishing the body with a new population of progenitor cells.
The purpose of this study is to evaluate the safety and efficacy of allogeneic bone marrow
 derived mesenchymal stem cell (AlloMSC) transplantation in patients with refractory SLE.
 Patients with Lupus nephritis and refractory to corticosteroid or cyclophosphamide trials
 will be enrolled in this trial. The treatment intervention includes a 24 hour pretreatment
 with cyclophosphamide followed by AlloMSC transplantation. Patients will be admitted to the
 in-patient service for the 3-5 days for the transplant treatment and will be followed up in
 the outpatient clinic. All baseline lupus serology, renal function panels will be obtained at
 pre-treatment admission. Post-transplantation follow-up visits will be at monthly intervals
 for lupus serology and renal function tests, and every 3 months for analysis of T regulatory
 population. The transplanted patients will be evaluated by an integrated team of
 rheumatologists, hematologists and bone marrow transplant specialists every month for the
 entire duration of the trial (2 years) and every 6-12 months thereafter.
Inclusion Criteria:

 -  All patients fulfilled the American College of Rheumatology (ACR) criteria of SLE, man
 or woman aged from 15 to 70 years old, SLEDAI≥8;

 -  Lupus nephritis with 24h urine protein≥1g;

 -  Refractory disease as determined by failure of the following regimens:

 -  Trial of corticosteroids (oral prednisone more than 20 mg/day);

 -  Trial of cyclophosphamide 0.4 ~ 0.6 / m2 every two weeks for six months, or other
 immunosuppressive drugs, such as MMF 2 g / day, for three months;

 -  Patients must sign an informed consent indicating that they are aware of the
 investigational nature of the study in keeping with the policy of the hospital;

 -  Willing to use contraception throughout the study and for 12 mos following treatment.

 Exclusion Criteria:

 -  Abnormal liver function (ALT higher than 3 times the normal value);

 -  End-stage renal failure;

 -  Severe heart and pulmonary failure, or other important organs damage;

 -  Undercontrolled infections

 -  Pregnant or breast feeding women, male or female who intended to recent pregnancy.