Cord blood-derived mesenchymal stromal cells in children with steroid-dependent nephrotic syndrome: a prospective phase II study

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ID: 315369
2026
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Abstract
Abstract Background Children with steroid-dependent nephrotic syndrome (SDNS) require long-term immunosuppressive (IS) treatment, significantly impacting their quality of life. Cord-blood-derived mesenchymal stromal cells (CB-MSCs) are multipotent stem cells with proven immunomodulatory properties. Methods We conducted an adaptive, open-label, single-arm, phase II trial with an adaptive second part to evaluate the efficacy of CB-MSCs in children aged 3–18 years with SDNS in remission for ≥ 6 months on IS therapy. In Part 1, patients received 3 intravenous infusions of CB-MSCs (1.5 × 10⁶/kg) at 1–2-week intervals, with rapid IS tapering and discontinuation after the third infusion. The primary endpoint was relapse-free survival at 6 months post-IS withdrawal, with a threshold of < 4/11 relapsing patients. In the adaptive Part 2, IS was discontinued before the first infusion to enhance CB-MSCs activity, and the dose was increased to 2 × 10⁶/kg, with a booster 4th infusion. A historical cohort of SDNS children tapering IS under standard care served as a post-hoc control. Results In Part 1, 9 patients were enrolled, and 7/9 (78%) relapsed, failing to meet the prespecified efficacy threshold. In Part 2, 11 patients were enrolled; 9 (82%) were in remission at 2 weeks post-third infusion and received the boosted dose. However, 6/11 (55%) relapsed within 6 months, with no significant difference in relapse-free survival compared to Part 1 (P = 0.25). Historical controls had significantly better relapse-free survival (P = 0.0007). Conclusion In children with SDNS, this novel therapy with CB-MSCs was safe but failed to improve relapse-free survival 6 months after IS withdrawal.
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Authors William Morello, Elisa Montelatici, Cristiana Lavazza, Silvia Budelli, Lorenza Lazzari, Giuseppe Puccio, Chiara Bulgaro, Emilio Carrino, Salvatore La Rosa, Chiara Tamburello, Teresa Nittoli, Laura Catenacci, Tiziana Montemurro, Luciana Ghio, Alberto Edefonti, Rosaria Giordano, Giovanni Montini
Journal clinical kidney journal
Year 2026
DOI
10.1093/ckj/sfag179
URL
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