UC-MSC Cell Therapy Study for SLE Patients

Phase 1

Not yet 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

• 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

• Status Verified: 2024-12
• Study First Submitted: 2024-12-11
• Study First Submitted QC: 2024-12-15
• Study First Posted: 2024-12-17
• Last Update Submitted: 2024-12-25
• Last Update Posted: 2024-12-27
• Study Start: 2025-01
• Primary Completion: 2026-06
• Study Completion: 2026-07

Recruitment & Eligibility

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

Inclusion Criteria

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.
3. Must have a positive ANA (≥1:160 titer) or positive dsDNA antibody test within 6 months of screening
4. An eGFR of ≥ 30 mL/min/1.73 m2 at screening
5. At least one SLE background therapy (e.g. immunosuppressant and/or antimalarial) is required for ≥ 12 weeks before the screening visit, must be at a stable dose for ≥ 8 weeks before the screening visit, and must remain stable until randomization and throughout study participation or have taken at least one background therapy and have discontinued due to intolerance.
6. Participants on corticosteroids must be at a stable dose for ≥ 4 weeks before the screening visit; the prednisone-equivalent dose cannot exceed 0.5mg/kg body weight and will be tapered during the study to 10mg or less by week 20 at the discretion of the investigators.
7. SLEDAI-2K ≥6 at the time of screening
8. Non-pregnant (via negative pregnancy test)/non-breast-feeding women and women with no intention to become pregnant/to breast-feed during the term of the trial, both women and men should commit to use a proper contraceptive
9. Participant able to provide written informed consent
10. Must be able to adhere to the study visit schedule and other protocol requirements.

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Exclusion Criteria

1. History of any non-systemic lupus erythematosus (non-SLE) disease that required treatment with oral or parenteral corticosteroids for more than a total of 2 weeks within the 3 months preceding informed consent to participate in the study.
2. History of dialysis within 12 months prior to signing the ICF or expected need for renal replacement therapy (dialysis or renal transplant) within a six-month period after enrollment
3. Concurrent enrollment in another interventional lupus clinical study within the predicted washout time of the investigational product prior to signing ICF
4. Receipt of any commercially available biologic agent within the washout period described above prior to signing the ICF
5. Receipt of IV pulse corticosteroid within 6 months prior to signing the ICF
6. Previous treatment with any type of cellular therapy e.g., Tregs or CAR-T cells
7. Major surgery within 3 months prior to signing the ICF or major surgery planned during the study period
8. Has other inflammatory diseases that might confound the evaluations of safety, including but not limited to rheumatoid arthritis (RA), psoriatic arthritis (PsA), RA/lupus overlap, psoriasis, Crohn's disease, or active Lyme disease
9. Confirmed positive test for active hepatitis B, hepatitis C, HIV or TB.
10. History of cancer, apart from squamous or basal cell carcinoma of the skin and cervical carcinoma in situ
11. Any other comorbidity which may render the participant unfit for study participation according to the investigator's judgement.

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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	SF-36 questionnaire	-
UC-MSC therapy	Clinical laboratory evaluations - Serology	-
UC-MSC therapy	Clinical laboratory evaluations - Biochemistry	-
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	-

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 the BILAG 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 prednisone-equivalent corticosteroid doses change at each visit	day 1 to day 168	Improvement is defined as a decrease in the required corticosteroid dose for patient.

Trial Locations

Locations (1)

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