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New treatment option for SLE
Official title UC-MSC Cell Therapy Study for Systemic Lupus Erythematosus (SLE) Patients
ClinicalTrials.gov ID: NCT06737380
What this study is testing
What is single dose of UC-MSCs?
single dose of UC-MSCs is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for sle.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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)...
- 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...
You likely can't join if
- History of any non-systemic lupus erythematosus (non-SLE) disease that required treatment with oral or parenteral corticosteroids for more than a...
- History of dialysis within 12 months prior to the screening visit or expected need for renal replacement therapy (dialysis or renal transplant)...
- 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...
- Treatment with an treatment 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).
See the full eligibility criteria
- 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...
- 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.
- 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 treatment 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).
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Charleston, South Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Charleston, South Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.