UC-MSC Cell Therapy Study for Systemic Lupus Erythematosus (SLE) Patients

A Phase I, Open-Label Study to Evaluate the Safety and Tolerability of Subcutaneous Administration of Umbilical Cord Derived - Mesenchymal Stromal Cell Therapy in Addition to Standard of Care as A Treatment For Active Systemic Lupus Erythematosus

The goal of this clinical trial is to evaluate the safety and effectiveness of UC-MSCs in adults with systemic lupus erythematosus (SLE).

The main questions this study aims to answer are:

1. Can UC-MSCs improve kidney function and reduce SLE disease activity?
2. Are UC-MSCs safe and well-tolerated in this patient population?

Participants in this study will:

• Receive UC-MSCs in a single dose in addition to standard of care treatment.
• Provide blood and urine samples for laboratory assessments, including biomarkers and immune profiling (e.g., cytokines, complement proteins, and autoantibodies).
• Attend regular clinic visits for physical exams, disease activity scoring, and imaging tests to monitor kidney health.
• Complete assessments for safety, such as monitoring for adverse events and changes in laboratory values.

This study aims to provide new insights into treatment options for SLE and lupus nephritis, addressing an unmet medical need in this population.

Inclusion Criteria

1. Age 18-75 years at the time of screening
2. Diagnosis of systemic lupus erythematosus (SLE), meeting at least 4 of the 11 criteria included in the American College of Rheumatology (ACR) Classification Criteria and/or 4 of the 17 criteria (with at least one of those being clinical and at least one being immunologic) included in the Systemic Lupus International Collaborating Clinics (SLICC) Criteria, at the screening visit.
3. Must have a positive ANA (≥1:160 titer) or positive anti-dsDNA antibody test within 6 months of the screening visit
4. An eGFR of ≥ 30 mL/min/1.73 m2 in the screening period
5. Prior SLE background therapy with at least one non-biologic medication (e.g. immunosuppressant and/or antimalarial), not including corticosteroids, is required for ≥ 12 weeks before the screening visit.
6. SLEDAI-2K ≥6 at the time of screening
7. Participant able and willing to provide written informed consent
8. Must be able and willing to adhere to the study visit schedule and other protocol requirements.

Exclusion Criteria

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 12 weeks preceding the screening visit.
2. History of dialysis within 12 months prior to the screening visit or expected need for renal replacement therapy (dialysis or renal transplant) within a six-month period after enrollment.
3. Use of prednisone >0.5 mg/kg/day (or equivalent corticosteroid) in the 4 weeks prior to the screening visit.
4. Any change or addition to a non-biologic immunosuppressant and/ or antimalarial regimen (not including corticosteroids) ≤ 12 weeks prior to the Screening visit.
5. Treatment with an interventional agent within the washout time of 90 days or 5 half-lives prior to Baseline (Day 0), whichever is longer.
6. Receipt of any commercially available biologic agent within the washout period described above prior to Baseline (Day 0).
7. Receipt of prior MSC therapy within the washout time of 52 weeks prior to Baseline (Day 0).
8. Previous treatment with any type of cellular therapy e.g., Tregs or CAR-T cells, with the exception of previous MSCs.
9. Major surgery within 90 days prior to Baseline (Day 0) or major surgery planned during the study period
10. Confirmed positive test for active hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or tuberculosis (TB).
11. Any active infection that has not been adequately treated or completely resolved prior to Baseline (Day 0).
12. History of cancer, apart from adequately treated squamous or basal cell carcinoma of the skin, or cervical carcinoma in situ
13. Pregnant or breast-feeding women and women with intention to become pregnant/to breast-feed during the duration of the trial.
14. Women and men who do not agree to use a medically acceptable form of contraception for the duration of the trial.
15. Any other comorbidity which may render the participant unfit for study participation according to the investigator's judgement.
16. Any other medical condition, which in the opinion of the investigator, may impact the quality or interpretation of the data obtained from the study.