Comparing human umbilical cord stem cells and low-dose IL-2 for lupus nephritis treatment
A Prospective, Single-center Study of Comparing the Efficacy and Safety of Human Umbilical Cord Mesenchymal Stem Cells and Low-dose IL-2 in the Treatment of Lupus Nephritis
This study is testing whether human umbilical cord stem cells work better than low-dose IL-2 to treat lupus nephritis in patients with active symptoms.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Drugs / interventions | rituximab, Infliximab, Adalimumab, Golimumab, Belimumab, Tocilizumab, cyclophosphamide |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05631717 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the efficacy and safety of human umbilical cord mesenchymal stem cells (MSCs) and low-dose interleukin-2 (IL-2) in treating lupus nephritis (LN). The research will involve patients with active LN who meet specific criteria, and it will assess the potential benefits of MSCs, which may enhance IL-2 production and promote regulatory T cell development. By conducting a prospective randomized trial, the study seeks to provide definitive evidence on whether MSCs are more effective than low-dose IL-2 for this condition.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with active lupus nephritis who meet specific classification criteria.
Not a fit: Patients who have received B cell depletion therapy within the last 24 weeks will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could offer a new and effective treatment option for patients suffering from lupus nephritis.
How similar studies have performed: While some small studies have shown promise with low-dose IL-2 for lupus nephritis, this approach comparing MSCs is relatively novel and lacks extensive prior randomized trials.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Nanjing, Jiangsu
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Linyu Geng, Doctor — The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study coordinator: Jun Liang, Doctor
- Email: 13505193169@139.com
- Phone: 13505193169
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.