UC-MSCs for Lupus

Overseen By Nadya Lisovoder, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: LiveKidney.Bio

Must be taking: Immunosuppressants, Antimalarials

Must not be taking: Biologics, Cellular therapy

Disqualifiers: Dialysis, Cancer, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

10 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

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.

Inclusion Criteria

I am not pregnant or breastfeeding and do not plan to during the trial. I will use contraception.

My kidney function test shows a score of 30 or higher.

Participant able to provide written informed consent

Exclusion Criteria

Any other comorbidity which may render the participant unfit for study participation according to the investigator judgment

I have used steroids for more than 2 weeks in the last 3 months for a condition other than SLE.

Confirmed positive test for active hepatitis B, hepatitis C, HIV or TB

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of UC-MSCs in addition to standard of care treatment

24 weeks

Regular clinic visits for physical exams, disease activity scoring, and imaging tests

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for adverse events and changes in laboratory values

24 weeks

Regular clinic visits

Treatment Details

Interventions

• UC-MSCs

Trial Overview 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.

Participant Groups

Group I: UC-MSC therapy Experimental Treatment 12 Interventions

Who Is Running the Clinical Trial?

LiveKidney.Bio

Lead Sponsor

Trials

1

Recruited

10+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Galilee CBR

Industry Sponsor

Trials

4

Recruited

570+