Trial reportStem cell research & therapy2026
Allogeneic umbilical cord-derived mesenchymal stromal cells for treatment of refractory lupus nephritis: a real-world study.
Trial report in Stem cell research & therapy, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00698191 (Phase I/IIa), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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Phase I/IIa: Allogeneic Bone Marrow Derived Mesenchymal Stem Cells Transplantation For Refractory Systemic Lupus Erythematosus
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Authors and funding
12 authors.
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Abstract
objectivesThis 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.
methodsA 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.
resultsCumulative 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.
conclusionUC-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.
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