Treatment of Refractory Systemic Lupus Erythematosus by Allogeneic Mesenchymal Stem Cells Derived From the Umbilical Cord

Inclusion Criteria

• •Age \> 18 years and \< 70 years.
• •Diagnosis of Systemic Lupus Erythematosus (SLE) according to the ACR criteria with positive antinuclear antibodies.
• •Subjects with sustained disease activity defined by a SELENA- SLEDAI SLE activity index ≥ 6 at baseline,
• •Inefficacy or adverse effects necessitating discontinuation of first and second line therapies of SLE including:
• •a. Prednisone orally ≥ 6 mg / day (or equivalent) for at least 28 days. b. At least one or more of the following immunosuppressive therapies for 3 months in total: i- Cyclophosphamide, iv bolus ≥500 mg / month for 3 months minimum ii- Mycophenolate mofetil, orally or equivalent at a dose\> 2000 mg / day for at least 90 days iii- Azathioprine orally at a dose\> 2 mg / kg / day for at least 90 days; iv- Methotrexate orally or parenterally, at doses \> 20mg / week for at least 90 days; v- Leflunomide orally, at a dose of\> 10-mg / day for at least 90 days; vi- Rituximab (anti-CD20) intravenous bolus 375 mg / m2, once a week for four weeks or total dose of 1 g twice a day for two weeks vii- Cyclosporine orally, at a dose of 2.5-5 mg / kg / day, for at least 90 days; viii- Belimumab intravenously at monthly bolus of 10 mg / kg infusion), for at least 3 months.
• •Patient who received treatment of SLE at stable doses for a minimum of 30 days prior to eligibility, including one of the following treatments: prednisone (or equivalent) alone or combined with antimalarial treatment, an anti-inflammatory steroidal and / or an immunosuppressant.
• •Negative pregnancy test for women of childbearing age.
• •For men and women : Using effective contraceptive methods during treatment and within 3 months after the end of treatment for men with her partner of childbearing age
• •Signed Informed Consent.
• •Affiliation to social security.