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Stem Cell Therapy

Phase I UC-MSC Study for SLE Patients

Phase 1
Waitlist Available
Research Sponsored by LiveKidney.Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
1. Age 18-75 years at the time of screening
2. Adults participants with the diagnosis of systemic lupus erythematosus (SLE) by meeting at least 4 of the11 criteria included in the American College of Rheumatology (ACR) classification and/or the Systemic Lupus International Collaborating Clinics (SLICC) criteria, at the screening visit.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 168
Awards & highlights
No Placebo-Only Group

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 is the study for?
This trial is for adults with systemic lupus erythematosus (SLE), specifically those who may have kidney involvement. Participants must be willing to receive a single dose of UC-MSCs, provide blood and urine samples, and undergo regular health monitoring. Details on specific inclusion or exclusion criteria are not provided.
What is being tested?
The study tests the safety and effectiveness of a single dose of Umbilical Cord-derived Mesenchymal Stem Cells (UC-MSCs) in SLE patients. It includes regular clinic visits, lab assessments for biomarkers and immune profiling, physical exams, disease activity scoring, and imaging tests to monitor kidney health.
What are the potential side effects?
While specific side effects are not listed here, participants will be closely monitored for any adverse events related to the treatment with UC-MSCs through physical examinations, laboratory evaluations including serology, biochemistry & hematology tests.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 168
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to day 168 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events
Secondary study objectives
Change from baseline in the BILAG Index score following administration
Change from baseline in the SLEDAI 2K following administration
Efficacy by prednisone-equivalent corticosteroid doses change at each visit
Other study objectives
A comparative analysis of pre-treatment versus post-treatment 24-hour urine protein levels
A comparative analysis of pre-treatment versus post-treatment Protein/Creatinine ratio in spot urine
A comparative analysis of pre-treatment versus post-treatment levels of Anti-ENA (Extractable Nuclear Antigens)
+7 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: UC-MSC therapyExperimental Treatment12 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Physical examination
2022
Completed Phase 3
~720
Electrocardiogram
2014
Completed Phase 2
~3060
Pregnancy Test
2021
N/A
~14130
Urinalysis
2019
Completed Phase 1
~70

Find a Location

Who is running the clinical trial?

LiveKidney.BioLead Sponsor
Medical University of South CarolinaOTHER
978 Previous Clinical Trials
7,400,917 Total Patients Enrolled
1 Trials studying Lupus
120 Patients Enrolled for Lupus
Galilee CBRIndustry Sponsor
3 Previous Clinical Trials
560 Total Patients Enrolled
~7 spots leftby Jun 2026
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