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

Phase 1

Recruiting

• Conditions: SLE; Lupus; Systemic Lupus Erthematosus; Systemic Lupus Erythematosus; Systemic Lupus Erythematosus (SLE)
• Interventions: Diagnostic Test: Physical examination; Diagnostic Test: Electrocardiogram; Other: SF-36 questionnaire; Diagnostic Test: Clinical laboratory evaluations - Serology; Diagnostic Test: Clinical laboratory evaluations - Biochemistry; Diagnostic Test: Clinical laboratory evaluations - Hematology; Diagnostic Test: Pregnancy Test; Diagnostic Test: Urinalysis; Diagnostic Test: SLE activity evaluation; Diagnostic Test: SLE biomarker profiling; Diagnostic Test: Cytokines and chemokine profiling; Biological: single dose of UC-MSCs; Other: PROMIS instruments

• Registration Number: NCT06737380
• Lead Sponsor: LiveKidney.Bio

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-15
• Study First Posted: 2024-12-17
• Study Start: 2025-01-07
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-22
• Last Update Posted: 2025-07-25
• Primary Completion: 2026-06
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
UC-MSC therapy	Physical examination	-
UC-MSC therapy	Electrocardiogram	-
UC-MSC therapy	Clinical laboratory evaluations - Biochemistry	-
UC-MSC therapy	SF-36 questionnaire	-
UC-MSC therapy	Clinical laboratory evaluations - Serology	-
UC-MSC therapy	Clinical laboratory evaluations - Hematology	-
UC-MSC therapy	Pregnancy Test	-
UC-MSC therapy	Urinalysis	-
UC-MSC therapy	SLE activity evaluation	-
UC-MSC therapy	SLE biomarker profiling	-
UC-MSC therapy	Cytokines and chemokine profiling	-
UC-MSC therapy	single dose of UC-MSCs	-
UC-MSC therapy	PROMIS instruments	-

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	day 1 to day 168	Analysis for the primary endpoint will be descriptive in nature. safety and tolerability will be measured by the number of AEs and SAEs observed. Adverse event incidents will be summarized descriptively. The severity grade of each recorded AE, and their relationship to study treatment will be analyzed. The action taken and outcome will also be analyzed accordingly.

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the SLEDAI 2K following administration	day 1 to day 168	Total score ranging from 0 to 105.; Interpretation: Scores are categorized to indicate disease activity: 0: No activity 1-5: Mild activity 6-10: Moderate activity 11-19: High activity; ≥20: Very high activity; Improvement is defined as a decrease in score.
Change from baseline in PROMIS(Patient-Reported Outcomes Measurement Information System) score	day 1 to day 168	Change from baseline in scores for quality of life, fatigue, pain, and depression as reported by the patient.
Change from baseline in the BILAG-2004 Index score following administration	day 1 to day 168	Organ involvement is categorized into grades: A: Severe active disease B: Moderate active disease C: Stable disease D: Resolved disease E: No involvement; Improvement is defined as an increase in score.
Efficacy by SRI-4 Responder assessment at Day 168.	day 1 to day 168	Improvement by SRI-4 is defined as a ≥4-point reduction in SLEDAI, with no significant worsening in BILAG or PGA.
Change from baseline in prednisone-equivalent corticosteroid doses at each visit performed.	day 1 to day 168.	Reduction in prednisone-equivalent corticosteroid dose from Day 1 to Day 168.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States