Phase I Study of Subcutaneous Umbilical Cord Mesenchymal Stromal Cell Therapy Added to Standard Treatment for Adults with Active Systemic Lupus Erythematosus

What this Trial Is About

Researchers are evaluating the safety and effectiveness of umbilical cord-derived mesenchymal stromal cells UC-MSCs in adults with systemic lupus erythematosus SLE, a condition that can affect kidney function and disease activity. This phase 1, open-label study aims to determine if UC-MSCs can improve kidney health and reduce disease symptoms while assessing how well this treatment is tolerated in patients receiving standard care. The trial addresses an unmet medical need in people living with SLE and lupus nephritis. Participants will receive a single subcutaneous dose of UC-MSCs alongside their usual treatment. The study includes regular clinic visits for physical exams, safety monitoring, disease activity scoring, and imaging tests to assess kidney function. Blood and urine samples will be collected at various time points to analyze biomarkers, immune profiles, and inflammatory markers. Participants will be observed for two to three hours after dosing and followed for safety and efficacy over a six-month period. During the study, participants will complete questionnaires on physical and mental health, provide laboratory samples for extensive testing, and undergo clinical evaluations including electrocardiograms, urinalysis, and pregnancy tests when applicable. The main outcomes measured include treatment-emergent adverse events and changes in disease activity scores, patient-reported outcomes, and corticosteroid use over 168 days. Regular monitoring ensures participant safety and tracks the impact of UC-MSC therapy on SLE symptoms and kidney health throughout the trial.

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