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

Last updated: March 25, 2025
Sponsor: Medical University of South Carolina
Overall Status: Active - Not Recruiting

Phase

2

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

NCT02633163
MUSC-UCMSC-001
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study is to evaluate the efficacy and safety of mesenchymal stem cells (MSCs) obtained from umbilical cords for the treatment of adults with systemic lupus erythematosus (SLE). The goal of this study is to determine if patients receiving an MSC infusion plus standard of care respond better than patients receiving placebo infusion plus standard of care.

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

Total Participants: 81
Treatment Group(s): 3
Primary Treatment: Low Dose Mesenchymal Stem Cells (MSCs)
Phase: 2
Study Start date:
November 18, 2018
Estimated Completion Date:
February 21, 2026

Study Description

A phase 2 multicenter (several medical research centers participating), placebo controlled, randomized (assigned by chance), double blind (neither the participant nor the investigator will know if active drug or placebo is assigned) trial to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) for the treatment of systemic lupus erythematosus (SLE) in adults.

The MSCs will be obtained from healthy donor umbilical cords and two doses of MSCs will be tested. The cells will be produced at the Medical University of South Carolina (MUSC) and will be shipped to other participating centers for patients with SLE. Participants will receive either active drug or placebo through a single IV infusion. All participants will receive standard of care and their safety will be monitored throughout the study.

Connect with a study center

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

  • University of California - San Diego

    San Diego, California 92093
    United States

    Site Not Available

  • Emory University

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • The Feinstein Institute for Medical Research

    Manhasset, New York 11030
    United States

    Site Not Available

  • University of Rochester Medical Center

    Rochester, New York 14642
    United States

    Site Not Available

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina 27599
    United States

    Site Not Available

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

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