UC-MSC Cell Therapy Study for SLE Patients

Eligibility Criteria

• 1. Age 18-75 years at the time of screening
• 2. Adults participants with the diagnosis of systemic lupus erythematosus (SLE) by meeting at least 4 of the11 criteria included in the American College of Rheumatology (ACR) classification and/or the Systemic Lupus International Collaborating Clinics (SLICC) criteria, at the screening visit.
• 3. Must have a positive ANA (≥1:160 titer) or positive dsDNA antibody test within 6 months of screening
• 4. An eGFR of ≥ 30 mL/min/1.73 m2 at screening
• 5. At least one SLE background therapy (e.g. immunosuppressant and/or antimalarial) is required for ≥ 12 weeks before the screening visit, must be at a stable dose for ≥ 8 weeks before the screening visit, and must remain stable until randomization and throughout study participation or have taken at least one background therapy and have discontinued due to intolerance.
• 6. Participants on corticosteroids must be at a stable dose for ≥ 4 weeks before the screening visit; the prednisone-equivalent dose cannot exceed 0.5mg/kg body weight and will be tapered during the study to 10mg or less by week 20 at the discretion of the investigators.
• 7. SLEDAI-2K ≥6 at the time of screening
• 8. Non-pregnant (via negative pregnancy test)/non-breast-feeding women and women with no intention to become pregnant/to breast-feed during the term of the trial, both women and men should commit to use a proper contraceptive
• 9. Participant able to provide written informed consent
• 10. Must be able to adhere to the study visit schedule and other protocol requirements.
• 1. History of any non-systemic lupus erythematosus (non-SLE) disease that required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the 3 months preceding informed consent to participate in the study.
• 2. History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a six-month period after enrollment
• 3. Concurrent enrollment in another interventional lupus clinical study within the predicted washout time of the investigational product prior to signing ICF
• 4. Receipt of any commercially available biologic agent within the washout period described above prior to signing the ICF
• 5. Receipt of IV pulse corticosteroid within 6 months prior to signing the ICF
• 6. Previous treatment with any type of cellular therapy e.g., Tregs or CAR-T cells
• 7. Major surgery within 3 months prior to signing the ICF or major surgery planned during the study period
• 8. Has other inflammatory diseases that might confound the evaluations of safety, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), RA/lupus overlap, psoriasis, Crohn's disease, or active Lyme disease
• 9. Confirmed positive test for active hepatitis B, hepatitis C, HIV or TB.
• 10. History of cancer, apart from squamous or basal cell carcinoma of the skin and cervical carcinoma in situ
• 11. Any other comorbidity which may render the participant unfit for study participation according to the investigator's judgement.