Actively Recruiting
A Phase I, Open-Label Study to Evaluate the Safety and Tolerability of Subcutaneous Administration of Umbilical Cord Derived Mesenchymal Stromal Cell Therapy with Standard Care for Active Systemic Lupus Erythematosus
Led by LiveKidney.Bio · Updated on 2025-09-11
10
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
L
LiveKidney.Bio
Lead Sponsor
M
Medical University of South Carolina
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Brief Title
UC-MSC Cell Therapy Study for Systemic Lupus Erythematosus (SLE) Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 to 75 years at screening
- Diagnosis of systemic lupus erythematosus meeting specific ACR or SLICC criteria
- Positive ANA (≥1:160 titer) or anti-dsDNA antibody test within 6 months
- Estimated glomerular filtration rate (eGFR) of at least 30 mL/min/1.73 m2
- At least 12 weeks of prior non-biologic SLE therapy excluding corticosteroids
- SLEDAI-2K score of 6 or higher at screening
- Ability and willingness to provide written informed consent
- Ability and willingness to adhere to study visit schedule and protocol requirements
You will not qualify if you...
- History of non-SLE disease requiring corticosteroids for more than 2 weeks within 12 weeks before screening
- History of dialysis within 12 months before screening or expected need for dialysis or transplant within 6 months after enrollment
- Use of prednisone over 0.5 mg/kg/day in 4 weeks before screening
- Changes to non-biologic immunosuppressant or antimalarial therapy within 12 weeks before screening
- Treatment with interventional agents or biologics within required washout periods prior to baseline
- Prior mesenchymal stromal cell therapy within 52 weeks before baseline
- Previous treatment with any cellular therapy except prior MSCs
- Major surgery within 90 days before baseline or planned during study
- Positive test for active hepatitis B, hepatitis C, HIV, or tuberculosis
- Active untreated infection at baseline
- History of cancer except certain treated skin or cervical cancers
- Pregnant or breastfeeding women or planning pregnancy during the trial
- Participants unwilling to use medically acceptable contraception during trial
- Any medical condition judged by investigator as unfit for participation or impacting data quality
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day 1 with 2 to 3 hours observation after dosing
Participants receive a single subcutaneous dose of UC-MSCs and are monitored for safety and tolerability.
1 baseline visit (Day 1) with observation for 2 to 3 hours after treatment
Duration - Up to 6 months
Participants are followed for safety assessments and clinical evaluations over the subsequent 6-month period.
Multiple follow-up visits including Days 14, 28, 56, 140, 168, and early termination visit
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
N
Nadya Lisovoder, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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