Phase
Condition
Systemic Lupus Erythematosus
Lupus
Cutaneous Lupus Erythematosus
Treatment
Low Dose Mesenchymal Stem Cells (MSCs)
Placebo Infusion
High Dose Mesenchymal Stem Cells (MSCs)
Clinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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
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
Study Design
Study Description
Connect with a study center
Cedars-Sinai Medical Center
Los Angeles, California 90048
United StatesSite Not Available
University of California - San Diego
San Diego, California 92093
United StatesSite Not Available
Emory University
Atlanta, Georgia 30322
United StatesSite Not Available
Northwestern University
Chicago, Illinois 60611
United StatesSite Not Available
The Feinstein Institute for Medical Research
Manhasset, New York 11030
United StatesSite Not Available
University of Rochester Medical Center
Rochester, New York 14642
United StatesSite Not Available
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina 27599
United StatesSite Not Available
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma 73104
United StatesSite Not Available
Medical University of South Carolina
Charleston, South Carolina 29425
United StatesSite Not Available
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