RecruitingPhase 1

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

United States10 participantsStarted 2025-01-07

Plain-language summary

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.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age 18-75 years at the time of screening
✓. 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.
✓. Must have a positive ANA (≥1:160 titer) or positive anti-dsDNA antibody test within 6 months of the screening visit
✓. An eGFR of ≥ 30 mL/min/1.73 m2 in the screening period
✓. 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.
✓. SLEDAI-2K ≥6 at the time of screening
✓. Participant able and willing to provide written informed consent
✓. Must be able and willing to adhere to the study visit schedule and other protocol requirements.

Exclusion criteria

What they're measuring

Incidence of Treatment-Emergent Adverse Events

Timeframe: day 1 to day 168

Trial details

NCT IDNCT06737380

SponsorLiveKidney.Bio

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

Contact for this trial

Nadya Lisovoder, MD

+972524753435 nadyal@galilee-cbr.com

View on ClinicalTrials.gov More SLE trials