ArticleScientific reports2026
Use of mesenchymal stromal cells derived from the Wharton's jelly of human umbilical cord for treating patients with steroid-resistant graft versus host disease: predicting clinical response by a validated immunopotency assay.
Article in Scientific reports, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
Steroid-resistant (SR) graft-versus-host disease (GvHD) remains a severe complication following allogeneic hematopoietic progenitor cell transplantation (HPCT). Mesenchymal stromal cell (MSC)-based therapies hold promise but face challenges in demonstrating clinical efficacy. This study investigates how in vitro immunopotency, a critical quality attribute (CQA) of MSC, correlates with patient outcomes to inform MSC-based therapy development for SR-GvHD. In this retrospective descriptive case series study, we evaluated 49 patients (median age: 10 years, interquartile range, IQR: 5-17; 19 females, 30 males) treated for post-allogeneic HPCT acute (N = 40) and chronic (N = 9) SR-GvHD across 4 tertiary hospitals (2018-2022). Clinical-grade MSCs derived from the Wharton's jelly (MSC, WJ) of the umbilical cord of unrelated donors were administered compassionately at a target dose of 1 × 10⁶ MSC, WJ/kg for a median of 4 infusions at days 1, 4 and once weekly thereafter (197 total infusions). MSC were stratified by immunopotency (in vitro suppression of mixed-lymphocyte reactions: >70% vs. 30%-70%) using a validated assay. An overall response was achieved in 71.4% of patients at day 28 post-treatment (complete response in 11 patients), with 1-year survival of 55.1%. Overall survival in acute GvHD responders was significantly different (P = 0.012) than in the non-responding population. This was especially relevant in acute GvHD patients with improved overall survival in the population under 12 years (P = 0.039). Remarkably, higher in vitro immunopotency strength of MSC, WJ batches correlated with improved clinical responses in patients under 12 years (N = 28, P = 0.039). MSC, WJ therapy proved safe and effective for patients with SR-GvHD, with clinical response rates correlating significantly with measured immunopotency levels. These findings highlight the importance of defining meaningful CQAs and validated release criteria to ensure the therapeutic consistency of MSC-based products.
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