Stem cell research & therapy · 2026
Allogeneic umbilical cord-derived mesenchymal stromal cells for treatment of refractory lupus nephritis: a real-world study.
Клиническое исследование I фазыКлиническое исследование II фазыСтатьяНазвание и аннотация: Перевод в очереди
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Zheng Yaru, Liu Shuman, Zeng Liuting, Luo Yong, Jin Ziyi, Yang Dapeng, Shi Yirui, Li Jizhe, Wang Hong, Feng Xuebing, Wang Dandan, Sun Lingyun
Аннотация
OBJECTIVES: This study aims to investigate the therapeutic effects of allogeneic umbilical cord-derived mesenchymal stromal cells (UC-MSCs) on refractory lupus nephritis (LN) and to evaluate the benefits for patients with different baseline renal functions.
METHODS: A total of 120 eligible patients with refractory LN were included in this study. Primary outcomes were the rate of renal response and relapse. Secondary outcomes included laboratory parameters and prednisone dosage. Adverse events (AEs) were recorded using telephone questionnaires and the medical record system.
RESULTS: Cumulative renal response rates at 3, 6, and 12 months were 38.3% (46/120), 53.3% (64/120), and 56.7% (68/120), respectively. Cumulative relapse rates at 6 and 12 months were 2.9% (2/68) and 8.8% (6/68), respectively. At the 12-month mark, estimated glomerular filtration rate (eGFR) significantly improved in chronic kidney disease stages 2 (CKD 2) and 3a (CKD 3a) patients (P = 0.032 and P = 0.046, respectively). Patients with a baseline eGFR of ≥ 45 ml/min/1.73 m² had a substantially higher renal response rate (66.3%). A baseline eGFR of ≥ 45 ml/min/1.73 m² was an independent predictor for renal response (OR = 2.104, 95% CI 1.063-4.167). One hundred twenty patients received 146 UC-MSCs infusions. Hyperacute AEs occurred in 2.1% (3/146) and infections in 10.9% (16/146). No severe AEs occurred.
CONCLUSION: UC-MSCs therapy shows a favorable safety profile and promising efficacy in refractory LN, markedly reducing proteinuria and improving renal function. The therapeutic efficacy is particularly prominent for patients with a baseline eGFR ≥ 45 ml/min/1.73 m². Trial registration The Clinical Trial Number is NCT00698191.
METHODS: A total of 120 eligible patients with refractory LN were included in this study. Primary outcomes were the rate of renal response and relapse. Secondary outcomes included laboratory parameters and prednisone dosage. Adverse events (AEs) were recorded using telephone questionnaires and the medical record system.
RESULTS: Cumulative renal response rates at 3, 6, and 12 months were 38.3% (46/120), 53.3% (64/120), and 56.7% (68/120), respectively. Cumulative relapse rates at 6 and 12 months were 2.9% (2/68) and 8.8% (6/68), respectively. At the 12-month mark, estimated glomerular filtration rate (eGFR) significantly improved in chronic kidney disease stages 2 (CKD 2) and 3a (CKD 3a) patients (P = 0.032 and P = 0.046, respectively). Patients with a baseline eGFR of ≥ 45 ml/min/1.73 m² had a substantially higher renal response rate (66.3%). A baseline eGFR of ≥ 45 ml/min/1.73 m² was an independent predictor for renal response (OR = 2.104, 95% CI 1.063-4.167). One hundred twenty patients received 146 UC-MSCs infusions. Hyperacute AEs occurred in 2.1% (3/146) and infections in 10.9% (16/146). No severe AEs occurred.
CONCLUSION: UC-MSCs therapy shows a favorable safety profile and promising efficacy in refractory LN, markedly reducing proteinuria and improving renal function. The therapeutic efficacy is particularly prominent for patients with a baseline eGFR ≥ 45 ml/min/1.73 m². Trial registration The Clinical Trial Number is NCT00698191.