SLEPhase 1NCT06737380
UC-MSC Cell Therapy Study for Systemic Lupus Erythematosus (SLE) Patients
A Phase 1 study testing Physical examination, Electrocardiogram and SF-36 questionnaire in people with SLE and Lupus, run by LiveKidney.Bio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SLE, Lupus, Systemic Lupus Erthematosus
- What is being tested?
- Physical examination, Electrocardiogram and SF-36 questionnaire
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2025to Jul 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-75 years at the time of screening
- Diagnosis of systemic lupus erythematosus (SLE), meeting at least 4 of the 11 criteria included in the American College of Rheumatology (ACR) Classification Criteria and/or 4 of the 17 criteria (with at least one of those being clinical and at least one being immunologic) included in the Systemic Lupus International Collaborating Clinics (SLICC) Criteria, at the screening visit.
- Must have a positive ANA (≥1:160 titer) or positive anti-dsDNA antibody test within 6 months of the screening visit
- An eGFR of ≥ 30 mL/min/1.73 m2 in the screening period
- Prior SLE background therapy with at least one non-biologic medication (e.g. immunosuppressant and/or antimalarial), not including corticosteroids, is required for ≥ 12 weeks before the screening visit.
- SLEDAI-2K ≥6 at the time of screening
- Participant able and willing to provide written informed consent
- Must be able and willing to adhere to the study visit schedule and other protocol requirements.
Who cannot join
- 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 12 weeks preceding the screening visit.
- History of dialysis within 12 months prior to the screening visit or expected need for renal replacement therapy (dialysis or renal transplant) within a six-month period after enrollment.
- Use of prednisone >0.5 mg/kg/day (or equivalent corticosteroid) in the 4 weeks prior to the screening visit.
- Any change or addition to a non-biologic immunosuppressant and/ or antimalarial regimen (not including corticosteroids) ≤ 12 weeks prior to the Screening visit.
- Treatment with an interventional agent within the washout time of 90 days or 5 half-lives prior to Baseline (Day 0), whichever is longer.
- Receipt of any commercially available biologic agent within the washout period described above prior to Baseline (Day 0).
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- Receipt of prior MSC therapy within the washout time of 52 weeks prior to Baseline (Day 0).
- Previous treatment with any type of cellular therapy e.g., Tregs or CAR-T cells, with the exception of previous MSCs.
- Major surgery within 90 days prior to Baseline (Day 0) or major surgery planned during the study period
- Confirmed positive test for active hepatitis B, hepatitis C, human immunodeficiency virus (HIV) or tuberculosis (TB).
- Any active infection that has not been adequately treated or completely resolved prior to Baseline (Day 0).
- History of cancer, apart from adequately treated squamous or basal cell carcinoma of the skin, or cervical carcinoma in situ
- Pregnant or breast-feeding women and women with intention to become pregnant/to breast-feed during the duration of the trial.
- Women and men who do not agree to use a medically acceptable form of contraception for the duration of the trial.
- Any other comorbidity which may render the participant unfit for study participation according to the investigator's judgement.
- Any other medical condition, which in the opinion of the investigator, may impact the quality or interpretation of the data obtained from the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Medical University of South Carolina
Charleston, South Carolina, 29425
Stephanie Dezzutti, 866-859-6107, lupusresearch@musc.edu
Kathleen Maksimowicz McKinnon, MD
About this study
Official title: 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
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:
Read more
- 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.
- Conditions
- SLE, Lupus, Systemic Lupus Erthematosus, Systemic Lupus Erythematosus, Systemic Lupus Erythematosus (SLE)
- Being tested
- Physical examination, Electrocardiogram, SF-36 questionnaire, Clinical laboratory evaluations - Serology, Clinical laboratory evaluations - Biochemistry
- Keywords
- systemic lupus erythematosus, SLE, Lupus
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical examinationDiagnostic test
The physical examination will be performed at the Screening visit and at each subsequent study and safety in clinic follow-up visit. The exam will include: measurement of vital signs (heart rate, peripheral arterial blood pressure, respiratory rate, and temperature), weight, height (at Screening visit only), cardiovascular and respiratory systems, abdominal examination, skin evaluation, mouth and eye evaluation, and neurological assessment. Abnormal findings will be recorded in the CRF.
ElectrocardiogramDiagnostic test
A twelve-lead electrocardiogram (ECG), including corrected QT interval (QTc interval), will be performed in all participants at the Screening visit.
SF-36 questionnaireOther
Patients will fill out the SF 36 survey, assessing physical and mental health outcomes prior to dosing and/or any other clinical assessments, on visits 1 (baseline), visit 5 (day 14), visit 6 (day 28), visit 11 (day 168) and early termination visit.
Clinical laboratory evaluations - SerologyDiagnostic test
Serologic testing for HIV, HBV, HCV, TB, and CMV will be performed; HBV and HCV PCR will be done only if serology is positive. Autoimmune tests (ANA, anti-ENA, total IgG, anti-nucleosome) will be done at Day 0 and end of study; ANA only at Screening if no positive ANA or anti-dsDNA in prior 6 months. Inflammatory markers (hs-CRP, ESR) will be tested at Day 0 and end of study. CBC with differential, biochemistry, anti-dsDNA, and complement C3/C4 will be assessed at each scheduled visit.
Clinical laboratory evaluations - BiochemistryDiagnostic test
The panel will include analysis of albumin, blood urea nitrogen (BUN), creatinine, glucose, uric acid, calcium, phosphorus, potassium, sodium, lactate dehydrogenase (LDH), total protein, magnesium, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin and hs-CRP. For biochemistry, 3 mL blood will be collected at each study visit. Results relating to inclusion criteria must be confirmed within 7 days prior to Day 1.
Clinical laboratory evaluations - HematologyDiagnostic test
The complete blood count (CBC) will include: hemoglobin, hematocrit, white blood cells (WBCs) with complete manual or automated differential (total neutrophils, lymphocytes, monocytes, eosinophils, basophils; absolute or percentage will be acceptable), red blood cells (RBCs), platelet count. For CBC, 1mL blood will be collected at each study visit.
Pregnancy TestDiagnostic test
A serum b-hCG pregnancy test will be performed for women of child-bearing potential at the Screening visit;urine pregnancy tests will be performed for women of child-bearing potential at each study visit noted above, including on Day 0 prior to study treatment.
Pregnancy tests are not required for women unable to become pregnant for one of the following reasons: Menopause confirmed by healthcare provider, verbally reported by a participant that she has had her uterus or both ovaries or both fallopian tubes removed.
UrinalysisDiagnostic test
General urinalysis will include analysis of pH, specific gravity, protein, glucose, ketones, bilirubin, urobilinogen, leukocytes, erythrocytes. In addition samples will be assessed for presence of urinary casts. Spot urine protein/creatinine measure will be done at each visit. If no casts are observed at Screening, then machine assessment of further urinary samples is allowed. For urinalysis, 10mL urine will be collected at each study visit.
SLE activity evaluationDiagnostic test
SLE status will be assessed using the Safety of Estrogens in Lupus Erythematosus National Assessment- SLE Disease Activity Index (SLEDAI 2K scale).SLE activity will also be assessed using British Isles Lupus Assessment Group (BILAG), physician global and participant global assessment allowing use of the Systemic Lupus Responder Index (SRI 4) and the BILAG-based Composite Lupus Assessment (BICLA) instruments to assess clinical response.
SLE biomarker profilingDiagnostic test
SLE biomarkers will be profiled at the study visit (Day 1) and at every subsequent follow up visit. For this purpose, urine and 10 ml blood will be collected.
Anti-ENA, Anti-dsDNA antibodies, total serum IgG levels, CBC, C3, C4, anti-nucleosome antibodies, erythrocyte sedimentation rate, CRP, protein/creatinine ratio in spot urine, 24-hour urine protein - Day 1 - Baseline and at end of study visit only; Mononuclear cell changes. This analysis includes lymphocyte subsets and innate immune cell subsets
Cytokines and chemokine profilingDiagnostic test
Samples will be analyzed for the following cytokines/chemokines: IFNγ, IL-6, IL-10, IL-18, TNFα, TGFβ1, CXCL10, CCL2, N-GAL, urine endothelin, KIM1. Serum and urine samples will be collected on Days 0, 28, 56, 140, 168, and early termination visit.
single dose of UC-MSCsBiological
participants will be treated on Baseline Day 1 with a UC-MSCs product administered subcutaneously. Participants will be observed for 2 to 3 hours after end of study treatment and then followed up for safety assessments over the subsequent 6-month period.
PROMIS instrumentsOther
PROMIS Fatigue, PROMIS, Depression, PROMIS Pain prior to dosing and/or any other clinical assessments, on visits 1 (baseline, day 0), visit 5 (day 14), visit 6 (day 28), visit 11 (day 168) and early termination visit.
| Study group | Role | What they receive |
|---|---|---|
| UC-MSC therapy | Experimental | Not described Receives: 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; Other: PROMIS instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
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.
Measured: day 1 to day 168
Secondary outcomes (5)
Change from baseline in the SLEDAI 2K following administration
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.
Measured: day 1 to day 168
Change from baseline in PROMIS(Patient-Reported Outcomes Measurement Information System) score
Change from baseline in scores for quality of life, fatigue, pain, and depression as reported by the patient. Scores range from 0 to 100. Higher scores indicate worse symptoms.
Measured: day 1 to day 168
Change from baseline in the BILAG-2004 Index score following administration
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.
Measured: day 1 to day 168
Efficacy by SRI-4 Responder assessment at Day 168.
Change from baseline in SRI-4, defined as a ≥4-point reduction in SLEDAI, with no significant worsening in BILAG or PGA. A higher SRI-4 response rate reflects greater clinical improvement.
Measured: day 1 to day 168
Change from baseline in prednisone-equivalent corticosteroid doses at each visit performed.
Reduction in prednisone-equivalent corticosteroid dose from Day 1 to Day 168.
Measured: day 1 to day 168.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start7 Jan 2025
- Primary completionJun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLEStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LiveKidney.Bio
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina, Galilee CBR
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737380
- Sponsor's protocol ID
- LK-23-01
- Status last verified
- Sep 2025
- First submitted
- 11 Dec 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06737380
- Acronym / sponsor ID
- LK-23-01
- Conditions
- SLE, Lupus, Systemic Lupus Erthematosus, Systemic Lupus Erythematosus, Systemic Lupus Erythematosus (SLE)
- Keywords
- systemic lupus erythematosus, SLE, Lupus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- LiveKidney.BioIndustry (pharma, biotech, devices)
- Collaborators
- Medical University of South Carolina, Galilee CBR
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UC-MSC therapy | Experimental | 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, Other: PROMIS instruments |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-75 years at the time of screening
- Diagnosis of systemic lupus erythematosus (SLE), meeting at least 4 of the 11 criteria included in the American College of Rheumatology (ACR) Classification Criteria and/or 4 of the 17 criteria (with at least one of those being clinical and at least one being immunologic) included in the Systemic Lupus International Collaborating Clinics (SLICC) Criteria, at the screening visit.
- Must have a positive ANA (≥1:160 titer) or positive anti-dsDNA antibody test within 6 months of the screening visit
- An eGFR of ≥ 30 mL/min/1.73 m2 in the screening period
- Prior SLE background therapy with at least one non-biologic medication (e.g. immunosuppressant and/or antimalarial), not including corticosteroids, is required for ≥ 12 weeks before the screening visit.
Key exclusion criteria (16 listed)
- 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 12 weeks preceding the screening visit.
- History of dialysis within 12 months prior to the screening visit or expected need for renal replacement therapy (dialysis or renal transplant) within a six-month period after enrollment.
- Use of prednisone >0.5 mg/kg/day (or equivalent corticosteroid) in the 4 weeks prior to the screening visit.
- Any change or addition to a non-biologic immunosuppressant and/ or antimalarial regimen (not including corticosteroids) ≤ 12 weeks prior to the Screening visit.
- Treatment with an interventional agent within the washout time of 90 days or 5 half-lives prior to Baseline (Day 0), whichever is longer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical examinationThe physical examination will be performed at the Screening visit and at each subsequent study and safety in clinic follow-up visit. The exam will include: measurement of vital signs (heart rate, peripheral arterial blood pressure, respiratory rate, and temperature), weight, height (at Screening visit only), cardiovascular and respiratory systems, abdominal examination, skin evaluation, mouth and eye evaluation, and neurological assessment. Abnormal findings will be recorded in the CRF. | Diagnostic test | UC-MSC therapy |
| ElectrocardiogramA twelve-lead electrocardiogram (ECG), including corrected QT interval (QTc interval), will be performed in all participants at the Screening visit. | Diagnostic test | UC-MSC therapy |
| SF-36 questionnairePatients will fill out the SF 36 survey, assessing physical and mental health outcomes prior to dosing and/or any other clinical assessments, on visits 1 (baseline), visit 5 (day 14), visit 6 (day 28), visit 11 (day 168) and early termination visit. | Other | UC-MSC therapy |
| Clinical laboratory evaluations - SerologySerologic testing for HIV, HBV, HCV, TB, and CMV will be performed; HBV and HCV PCR will be done only if serology is positive. Autoimmune tests (ANA, anti-ENA, total IgG, anti-nucleosome) will be done at Day 0 and end of study; ANA only at Screening if no positive ANA or anti-dsDNA in prior 6 months. Inflammatory markers (hs-CRP, ESR) will be tested at Day 0 and end of study. CBC with differential, biochemistry, anti-dsDNA, and complement C3/C4 will be assessed at each scheduled visit. | Diagnostic test | UC-MSC therapy |
| Clinical laboratory evaluations - BiochemistryThe panel will include analysis of albumin, blood urea nitrogen (BUN), creatinine, glucose, uric acid, calcium, phosphorus, potassium, sodium, lactate dehydrogenase (LDH), total protein, magnesium, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin and hs-CRP. For biochemistry, 3 mL blood will be collected at each study visit. Results relating to inclusion criteria must be confirmed within 7 days prior to Day 1. | Diagnostic test | UC-MSC therapy |
| Clinical laboratory evaluations - HematologyThe complete blood count (CBC) will include: hemoglobin, hematocrit, white blood cells (WBCs) with complete manual or automated differential (total neutrophils, lymphocytes, monocytes, eosinophils, basophils; absolute or percentage will be acceptable), red blood cells (RBCs), platelet count. For CBC, 1mL blood will be collected at each study visit. | Diagnostic test | UC-MSC therapy |
| Pregnancy TestA serum b-hCG pregnancy test will be performed for women of child-bearing potential at the Screening visit;urine pregnancy tests will be performed for women of child-bearing potential at each study visit noted above, including on Day 0 prior to study treatment. Pregnancy tests are not required for women unable to become pregnant for one of the following reasons: Menopause confirmed by healthcare provider, verbally reported by a participant that she has had her uterus or both ovaries or both fallopian tubes removed. | Diagnostic test | UC-MSC therapy |
| UrinalysisGeneral urinalysis will include analysis of pH, specific gravity, protein, glucose, ketones, bilirubin, urobilinogen, leukocytes, erythrocytes. In addition samples will be assessed for presence of urinary casts. Spot urine protein/creatinine measure will be done at each visit. If no casts are observed at Screening, then machine assessment of further urinary samples is allowed. For urinalysis, 10mL urine will be collected at each study visit. | Diagnostic test | UC-MSC therapy |
| SLE activity evaluationSLE status will be assessed using the Safety of Estrogens in Lupus Erythematosus National Assessment- SLE Disease Activity Index (SLEDAI 2K scale).SLE activity will also be assessed using British Isles Lupus Assessment Group (BILAG), physician global and participant global assessment allowing use of the Systemic Lupus Responder Index (SRI 4) and the BILAG-based Composite Lupus Assessment (BICLA) instruments to assess clinical response. | Diagnostic test | UC-MSC therapy |
| SLE biomarker profilingSLE biomarkers will be profiled at the study visit (Day 1) and at every subsequent follow up visit. For this purpose, urine and 10 ml blood will be collected. Anti-ENA, Anti-dsDNA antibodies, total serum IgG levels, CBC, C3, C4, anti-nucleosome antibodies, erythrocyte sedimentation rate, CRP, protein/creatinine ratio in spot urine, 24-hour urine protein - Day 1 - Baseline and at end of study visit only; Mononuclear cell changes. This analysis includes lymphocyte subsets and innate immune cell subsets | Diagnostic test | UC-MSC therapy |
| Cytokines and chemokine profilingSamples will be analyzed for the following cytokines/chemokines: IFNγ, IL-6, IL-10, IL-18, TNFα, TGFβ1, CXCL10, CCL2, N-GAL, urine endothelin, KIM1. Serum and urine samples will be collected on Days 0, 28, 56, 140, 168, and early termination visit. | Diagnostic test | UC-MSC therapy |
| single dose of UC-MSCsparticipants will be treated on Baseline Day 1 with a UC-MSCs product administered subcutaneously. Participants will be observed for 2 to 3 hours after end of study treatment and then followed up for safety assessments over the subsequent 6-month period. | Biological | UC-MSC therapy |
| PROMIS instrumentsPROMIS Fatigue, PROMIS, Depression, PROMIS Pain prior to dosing and/or any other clinical assessments, on visits 1 (baseline, day 0), visit 5 (day 14), visit 6 (day 28), visit 11 (day 168) and early termination visit. | Other | UC-MSC therapy |
Primary outcome
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.
5 secondary outcomes
Change from baseline in the SLEDAI 2K following administration
Time frame: day 1 to day 168
Change from baseline in PROMIS(Patient-Reported Outcomes Measurement Information System) score
Time frame: day 1 to day 168
Change from baseline in the BILAG-2004 Index score following administration
Time frame: day 1 to day 168
Efficacy by SRI-4 Responder assessment at Day 168.
Time frame: day 1 to day 168
Change from baseline in prednisone-equivalent corticosteroid doses at each visit performed.
Time frame: day 1 to day 168.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Physical examination, Electrocardiogram and SF-36 questionnaire in people with SLE and Lupus, run by LiveKidney.Bio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadya Lisovoder, MD (+972524753435, nadyal@galilee-cbr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: day 1 to day 168). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.