UC-MSC Cell Therapy Study for SLE Patients

Launched by LIVEKIDNEY.BIO · Dec 15, 2024

Keywords

ClinConnect Summary

The UC-MSC Cell Therapy Study is a clinical trial designed to explore the safety and effectiveness of a new treatment using umbilical cord mesenchymal stem cells (UC-MSCs) for adults with systemic lupus erythematosus (SLE), a condition that can affect various organs in the body, including the kidneys. The main goals of this study are to determine if UC-MSCs can help improve kidney function and reduce disease activity in people with SLE, while also ensuring that the treatment is safe and well-tolerated.

To participate in this trial, individuals must be between 18 and 75 years old and have a diagnosis of SLE, verified by specific criteria. Participants will receive a single dose of UC-MSCs along with their regular treatment and will attend regular clinic visits for health assessments. During these visits, they will provide blood and urine samples, undergo physical exams, and have their kidney health monitored. The study is currently recruiting, and it aims to provide valuable insights into new treatment options for SLE and lupus-related kidney problems.

Gender

ALL

Eligibility criteria

• 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.
• 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.