NCT06485648
Mesenchymal Stem Cell Transfusion for the Treatment of Refractory Lupus Nephritis
Not Yet Recruiting · Early Phase 1 · Chinese PLA General Hospital · registry updated 2024-07-03
Inclusion and exclusion lines below are quoted from ClinicalTrials.gov. No match score is shown, because a score needs a person's age, biomarkers, and treatment dates. Confirm the record with the study team.
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....
Inclusion
- years old (including 18 and 65 years old, gender is not limited);
- According to the revised criteria of ACR, the diagnosis of SLE was confirmed;
- 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
- Do not agree to sign the informed consent;
- Pregnancy, lactation or do not agree to take effective contraceptive measures during the trial and within 12 months after the trial;
- Kidney biopsy indicated chronic nephritis (extensive glomerular sclerosis, extensive fibrous crescent formation, extensive interstitial fibrosis, tubule atrophy);
- In addition to SLE, patients with other autoimmune diseases (dermatomyositis/polymyositis, mixed connective tissue disease, scleroderma, rheumatoid arthritis, etc.);
- 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;
- Severe and uncontrollable cardiovascular disease, neurological disease, lung disease, endocrine or gastrointestinal disease;