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NCT06737380 · ClinicalTrials.gov registry record · Phase 1
UC-MSC Cell Therapy Study for Systemic Lupus Erythematosus (SLE) Patients
A Phase 1 study of Systemic Lupus Erythematosus and Systemic Lupus Erythematosus (SLE), sponsored by LiveKidney.Bio.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT06737380: Recruiting Phase 1 study of Systemic Lupus Erythematosus and Systemic Lupus Erythematosus (SLE), sponsored by LiveKidney.Bio.
NCT06737380 is a Phase 1 study of Systemic Lupus Erythematosus and Systemic Lupus Erythematosus (SLE) that is actively recruiting participants, run by LiveKidney.Bio. The registered enrollment target is 10 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06737380, a Phase 1 study of Systemic Lupus Erythematosus and Systemic Lupus Erythematosus (SLE), is actively recruiting participants, sponsored by LiveKidney.Bio.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DIAGNOSTIC_TEST Physical examination
- DIAGNOSTIC_TEST Electrocardiogram
- OTHER SF-36 questionnaire
- DIAGNOSTIC_TEST Clinical laboratory evaluations - Serology
- DIAGNOSTIC_TEST Clinical laboratory evaluations - Biochemistry
Study Locations (1)
South Carolina
- Medical University of South Carolina - Charleston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2025-01-07 |
| Est. Completion | 2026-07 |
| Phase | Phase 1 |
What NCT06737380 shows while recruiting
NCT06737380 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (97% lower).
The record links to 5 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 5 interventions - of which Physical examination is the first listed.
NCT06737380 reports a single indexed study location in South Carolina.
Frequently Asked Questions
What is clinical trial NCT06737380 about?
NCT06737380 is a clinical study titled "UC-MSC Cell Therapy Study for Systemic Lupus Erythematosus (SLE) Patients". 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...
What is the current status of trial NCT06737380?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 10 participants. The study started on 2025-01-07. Estimated completion is 2026-07.
What conditions does trial NCT06737380 study?
This clinical trial studies the following conditions: Systemic Lupus Erythematosus, Systemic Lupus Erythematosus (SLE), Lupus, SLE, Systemic Lupus Erthematosus.
What interventions are being tested in trial NCT06737380?
The interventions under investigation include: Physical examination (DIAGNOSTIC_TEST), Electrocardiogram (DIAGNOSTIC_TEST), SF-36 questionnaire (OTHER), Clinical laboratory evaluations - Serology (DIAGNOSTIC_TEST), Clinical laboratory evaluations - Biochemistry (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06737380?
This trial is sponsored by LiveKidney.Bio, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06737380 being conducted?
This trial has 1 study location across South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06737380's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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