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NOT YET RECRUITING

NCT06485648

EARLY_PHASE1

Mesenchymal Stem Cell Transfusion for the Treatment of Refractory Lupus Nephritis

Sponsor: Chinese PLA General Hospital

View on ClinicalTrials.gov

Summary

Lupus nephritis (LN) is the most common and serious complication of systemic lupus erythematosus (SLE), which can lead to permanent kidney injury and uremia. At present, the combination of glucocorticoids and immunosuppressants is still the first line of clinical treatments. Only about 20%-30% of patients with LN can achieve a complete response. In addition, attainment of clinical remission does not necessarily reflect improvement in the kidney tissues, A substantial proportion of patients who show a clinical response to treatment still have histological findings in their kidney biopsy samples that are consistent with active kidney disease after clinical complete remission. Because of the complexity of refractory lupus nephritis, there is no uniform and effective treatment for them. Mesenchymal stem cells (MSCs) are a class of pluripotent stem cells, that can secrete hundreds of cytokines to participate in immune regulation, anti-inflammatory and anti-fibrosis processes, etc., so they have been actively explored for the treatment of autoimmune diseases which Including systemic lupus erythematosus and lupus nephritis recently. Therefore, MSCs have been considered as a potential therapeutic regimen for the treatment of refractory LN. Several clinical trials have been performed, but the results have been inconsistent and the outcome indicators of treatment were not verified by pathological findings. Therefore, this trial wishes to investigate whether MSCs can improve renal recovery in patients with refractory lupus nephritis and to evaluate the effectiveness of treatment by renal biopsy.

Official title: Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Transfusion for the Treatment of Refractory Lupus Nephritis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-10-01

Completion Date

2029-10-01

Last Updated

2024-07-03

Healthy Volunteers

Conditions

Lupus Nephritis

Interventions

BIOLOGICAL

Umbilical cord mesenchymal stem cells

Treatment: G(glucocorticoid) + i.v. uc-MSC (1×106 cells/Kg)

DRUG

Normal saline

Control: G(glucocorticoid) + i.v. Normal saline

Inclusion Criteria: 1. 18-65 years old (including 18 and 65 years old, gender is not limited); 2. According to the revised criteria of ACR, the diagnosis of SLE was confirmed; 3. Diagnosed with LN (III, IV or III+V or IV+V) active lesions according to the 2016 revised ISN/RPS renal pathological classification criteria and unachieved a partial or complete response within 6-12 month of starting standard therapy. \- Exclusion Criteria: 1. Do not agree to sign the informed consent; 2. Pregnancy, lactation or do not agree to take effective contraceptive measures during the trial and within 12 months after the trial; 3. Kidney biopsy indicated chronic nephritis (extensive glomerular sclerosis, extensive fibrous crescent formation, extensive interstitial fibrosis, tubule atrophy); 4. In addition to SLE, patients with other autoimmune diseases (dermatomyositis/polymyositis, mixed connective tissue disease, scleroderma, rheumatoid arthritis, etc.); 5. Severe hepatic dysfunction (total bilirubin exceeding 14mg/L, AST or ALT exceeding 1.5 times the upper limit of normal) or estimated glomerular filtration rate (eGFR) ≤45ml/min per 1.73 m2; 6. Severe and uncontrollable cardiovascular disease, neurological disease, lung disease, endocrine or gastrointestinal disease; 7. Any substantial organ surgery performed within 12 weeks prior to screening is not tolerated by the test, or elective surgery is required during the study period; 8. A history of malignant tumors, including solid tumors and malignant hematological tumors (except resected or cured basal cell carcinoma of the skin, squamous cell carcinoma and cervical intraepithelial neoplasia); 9. A history of bone marrow, lung, liver, pancreas, or small intestine transplantation; 10. A current or recent (within 4 weeks prior to enrollment) history of serious active or recurrent bacterial, viral, fungal, parasitic or other infections (including but not limited to tuberculosis and atypical mycobacterial disease, hepatitis B and C, HIV infection, shingles, but not tinea onychomycosis); 11. Had received live vaccine within 12 weeks prior to enrollment, or expected to require/receive live vaccine (other than shingles vaccine) during the study period; 12. Suffering from a serious mental illness (e.g. schizophrenia, bipolar personality disorder) that affects communication and decision-making; 13. Patients with severe allergies, who have a history of allergies to biological products, hypersensitivity reactions or other serious reactions; 14. Participate in other clinical trials within 30 days before enrollment. \-