The Study of Comparing the Efficacy and Safety of Human Umbilical Cord MSCs and Low-dose IL-2 in the Treatment of LN

Launched by THE AFFILIATED NANJING DRUM TOWER HOSPITAL OF NANJING UNIVERSITY MEDICAL SCHOOL · Nov 20, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for Lupus Nephritis (LN), a condition that affects the kidneys in people with Systemic Lupus Erythematosus (SLE). The trial aims to compare the effectiveness and safety of human umbilical cord mesenchymal stem cells, which are special cells that can help repair tissues, with low doses of a medication called IL-2. The goal is to find out which treatment works better for patients with active LN.

To participate in this study, you must be between 18 and 65 years old and have active lupus nephritis, meeting specific medical criteria. The researchers will be looking for patients who have certain symptoms and test results that indicate their lupus is currently active. If you join the trial, you will receive one of the two treatments and be monitored for safety and effectiveness. It’s important to know that there are some restrictions on who can participate, including not having certain health conditions or recent treatments that could interfere with the study. If you're interested in learning more or think you might qualify, please speak with your healthcare provider.

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Eligibility criteria

• Inclusion Criteria:
• Only patients with active lupus nephritis who meet all of the following criteria are eligible for inclusion in this study:
• • Before random assignment, records show that it meets at least 4 of the 11 SLE classification criteria recommended by ACR in 1997.
• • Age: age \> 18 years old, ≤ 65 years old when obtaining informed consent
• • SLEDAI-2K score ≥ 6
• • Urinary total protein / creatinine ratio \> 1.0 or 24-hour urinary protein \> 1.0g, with or without microscopic hematuria
• • If they are fertile, they must agree to use effective contraception during the trial.
• • In the case of women of childbearing age, urinary pregnancy and serum pregnancy tests should be negative.
• • Voluntarily sign informed consent and comply with the requirements of the research programme
• Exclusion Criteria:
• Patients who met any of the following criteria could not be enrolled in this study:
• • Patients who had received rituximab or any other B cell depletion therapy within 24 weeks before screening; patients who received unstable doses of mycophenolate mofetil, cyclophosphamide or other immunosuppressants (including Cyclosporine, Tacrolimus, Tripterygium wilfordii, Leflunomide, Azathioprine, Iguratimod) within the first 12 weeks of screening. Received biological agents or small molecule targeted drugs for immune diseases within 4 weeks before screening, such as Etanercept, Infliximab, Adalimumab Solution, Golimumab, Belimumab, Tocilizumab or JAK inhibitors;
• • Plasmapheresis or immunosorbent therapy within 12 weeks before screening.
• • Accompanied by severe and uncontrolled cardiovascular diseases, nervous system diseases, lung diseases, liver diseases, endocrine and gastrointestinal diseases.
• • Current or recent (within 4 weeks before random allocation) a history of severe active or recurrent bacterial, viral, fungal, parasitic or other infections (including, but not limited to, tuberculosis and atypical mycobacterial diseases, hepatitis B and C, HIV infection, herpes zoster, but excluding onychomycosis). Or any infected person who needs hospitalization and intravenous antibiotic treatment within 4 weeks before screening or any infected person who needs treatment within 2 weeks before screening.
• • Any major surgery has been performed within 12 weeks before screening, or major surgery is required during the study period, which the researchers believe will pose an unacceptable risk to the patient;
• • Live vaccine will be given within 12 weeks before random allocation, or live vaccine is expected to be needed / received during the study (except for herpes zoster vaccination).
• • Patients with a history of malignant tumors, including solid tumors and hematological malignancies (except for excised or cured basal cell carcinoma of the skin);
• • Pregnant or lactating women.