Status:
NOT_YET_RECRUITING
Mesenchymal Stem Cell Transfusion for the Treatment of Refractory Lupus Nephritis
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18-65 years
Phase:
EARLY_PHASE1
Brief 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 glucocortic...
Detailed Description
Systemic lupus erythematosus (SLE) is an autoimmune disease in which the immune system loses its immune tolerance to endogenous nuclear substances due to unknown reasons. The incidence and prevalence ...
Eligibility Criteria
Inclusion
- 18-65 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.
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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;
- 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;
- 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);
- A history of bone marrow, lung, liver, pancreas, or small intestine transplantation;
- 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);
- 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;
- Suffering from a serious mental illness (e.g. schizophrenia, bipolar personality disorder) that affects communication and decision-making;
- Patients with severe allergies, who have a history of allergies to biological products, hypersensitivity reactions or other serious reactions;
- Participate in other clinical trials within 30 days before enrollment.
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Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2029
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT06485648
Start Date
October 1 2024
End Date
October 1 2029
Last Update
July 3 2024
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