Actively Recruiting
UC-MSC Cell Therapy Study for Systemic Lupus Erythematosus (SLE) Patients
Led by LiveKidney.Bio · Updated on 2025-09-11
10
Participants Needed
1
Research Sites
77 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
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.
CONDITIONS
Official 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 (SLE) meeting American College of Rheumatology or Systemic Lupus International Collaborating Clinics criteria
- Positive ANA (≥1:160 titer) or positive anti-dsDNA antibody test within 6 months
- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73 m2 at screening
- Prior treatment with at least one non-biologic SLE medication (excluding corticosteroids) for 12 or more weeks before screening
- SLE Disease Activity Index (SLEDAI-2K) score of 6 or higher at screening
- Able and willing to provide written informed consent
- Willing and able to follow study visits and protocol requirements
You will not qualify if you...
- History of non-SLE disease requiring oral or parenteral corticosteroids for more than 2 weeks within 12 weeks before screening
- History of dialysis within 12 months before screening or expected need for renal replacement therapy within 6 months after enrollment
- Use of prednisone over 0.5 mg/kg/day or equivalent corticosteroid within 4 weeks before screening
- Change or addition to non-biologic immunosuppressant or antimalarial medication within 12 weeks before screening
- Treatment with interventional agents or biologic therapy within washout periods prior to baseline
- Prior mesenchymal stromal cell (MSC) therapy within 52 weeks before baseline
- Previous treatment with cellular therapies other than MSCs
- Major surgery within 90 days before baseline or planned during the study
- Active hepatitis B, hepatitis C, HIV, or tuberculosis infection
- Any active infection not fully treated before baseline
- History of cancer except treated skin or cervical carcinoma in situ
- Pregnant or breastfeeding women, or those intending pregnancy or breastfeeding
- Not agreeing to use medically acceptable contraception during the trial
- Other medical conditions making participation unsafe or affecting study data according to investigator judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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