A Phase I, Open-Label Study to Evaluate the Safety and Tolerability of Subcutaneous Administration of Umbilical Cord Derived - Mesenchymal Stromal Cell Therapy in Addition to Standard of Care as A Treatment For Active Systemic Lupus Erythematosus
Overview
- Phase
- Phase 1
- Intervention
- Physical examination
- Conditions
- SLE
- Sponsor
- LiveKidney.Bio
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
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:
- Can UC-MSCs improve kidney function and reduce SLE disease activity?
- 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
UC-MSC therapy
Intervention: Physical examination
UC-MSC therapy
Intervention: Electrocardiogram
UC-MSC therapy
Intervention: SF-36 questionnaire
UC-MSC therapy
Intervention: Clinical laboratory evaluations - Serology
UC-MSC therapy
Intervention: Clinical laboratory evaluations - Biochemistry
UC-MSC therapy
Intervention: Clinical laboratory evaluations - Hematology
UC-MSC therapy
Intervention: Pregnancy Test
UC-MSC therapy
Intervention: Urinalysis
UC-MSC therapy
Intervention: SLE activity evaluation
UC-MSC therapy
Intervention: SLE biomarker profiling
UC-MSC therapy
Intervention: Cytokines and chemokine profiling
UC-MSC therapy
Intervention: single dose of UC-MSCs
UC-MSC therapy
Intervention: PROMIS instruments
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events
Time Frame: 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 Outcomes
- Change from baseline in the SLEDAI 2K following administration(day 1 to day 168)
- Change from baseline in PROMIS(Patient-Reported Outcomes Measurement Information System) score(day 1 to day 168)
- Change from baseline in the BILAG-2004 Index score following administration(day 1 to day 168)
- Efficacy by SRI-4 Responder assessment at Day 168.(day 1 to day 168)
- Change from baseline in prednisone-equivalent corticosteroid doses at each visit performed.(day 1 to day 168.)