Phase 2 Trial of Mesenchymal Stem Cells in Systemic Lupus Erythematosus (MiSLE)

Inclusion Criteria: * Patients between 18 and 65 years old, male or female, of any race * Historical presence of at least 4 of 11 of the ACR Classification Criteria * Evidence of a positive ANA (≥1:80 titer) or positive dsDNA antibody test within 6 months of screening * Clinically active SLE determined by SLEDAI score ≥6 and the presence of at least one BILAG A or BILAG B at screening, despite standard-of-care therapy * If the patient has a BILAG A or BILAG B score in the renal organ system, he/she must have completed at least 6 months of therapy for the current episode of nephritis prior to Screening. Therapy must include at least 6 months of mycophenolate or at least 3 months of cyclophosphamide followed by mycophenolate or azathioprine * Able and willing to give written informed consent Exclusion Criteria: * Active CNS lupus affecting mental status * Active lupus nephritis requiring dialysis * Laboratory exclusions: eGFR \<30, WBC \<2.0/mm3, hemoglobin \<8 g/dL, platelet count \<30,000/mm3, liver enzymes AST or ALT \>4 times upper limit normal. * Positive testing for HIV, hepatitis B or hepatitis C, tuberculosis (TB), or chest X-ray (CXR) findings consistent with TB or latent fungal infection. * History of malignant neoplasm within the last 5 years, except for adequately treated cancers of the skin (basal or squamous cell) or carcinoma in situ of the uterine cervix * Pregnant or breast feeding * A woman of childbearing potential (not post-menopausal or surgically steril…