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 6months of screening

• Clinically active SLE determined by SLEDAI score ≥6 and the presence of at least oneBILAG 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 musthave completed at least 6 months of therapy for the current episode of nephritisprior to Screening. Therapy must include at least 6 months of mycophenolate or atleast 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 chestX-ray (CXR) findings consistent with TB or latent fungal infection.

• History of malignant neoplasm within the last 5 years, except for adequately treatedcancers of the skin (basal or squamous cell) or carcinoma in situ of the uterinecervix

• Pregnant or breast feeding

• A woman of childbearing potential (not post-menopausal or surgically sterile) who isnot willing to use adequate contraception

• History of renal transplantation

• Herpes zoster within the past 90 days or any infection requiring hospitalization orintravenous or intramuscular antibiotics within the past 60 days

• Clinically significant EKG or chest X-ray changes

• Any other medical condition, related or unrelated to SLE, that in the opinion of theinvestigator would render the patient inappropriate or too unstable to completestudy protocol

• Use of prednisone >0.5 mg/kg/day (or equivalent corticosteroid) within 1 month ofBaseline visit

• Change or addition to immunosuppressant regimen within 3 months of Baseline visit (except corticosteroids); Use of other experimental therapeutic agents within 3months of Baseline visit

• Having received belimumab within 2 months of Baseline, or having received rituximabor other B cell depleting biologic therapy within 6 months of Baseline.

• Comorbidities requiring corticosteroid therapy

• Current substance abuse or recent (within one year) history of substance abuse