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MSC treatment for patients with SR-aGvHD: Long-term results from a phase III trial
Around 80% of patients with chronic graft-versus-host disease (cGvHD) have a history of acute GvHD (aGvHD), and tend to have worse outcomes compared with de novo cGVHD, making modulating aGvHD development and preventing its evolution to cGvHD an important therapeutic objective.1 Initial results from an open-label, multicenter, randomized phase III trial (NCT02241018) of mesenchymal stromal cells (MSCs), an aGvHD prophylactic and treatment, plus aGvHD therapy in patients with steroid-resistant aGvHD (SR-aGvHD) across nine centers in China (N = 198) found a reduction in the incidence and severity of cGvHD. The 5-year follow-up from this trial (n = 185; MSC group, n = 101; control group, n = 84) and a post-hoc analysis of the underlying mechanism of MSCs were published in Experimental Hematology & Oncology by Zhao, et al.1
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Key learnings |
Patients in the MSC group had a reduced cumulative incidence of cGvHD (42.0% vs 67.1%; HR, 2.19; 95% CI, 1.47–3.27; p < 0.001) and severe cGvHD (11.0% vs 27.4%; HR, 2.85; 95% CI, 1.40–5.80; p = 0.003) compared with the control group. |
MSC treatment improved 5-year OS (60.4% vs 41.7%; HR, 0.63; 95% CI, 0.42–0.94; p = 0.023) and CRFS (33.9% vs 20.9%; HR, 0.67; 95% CI, 0.48–0.93; p = 0.017) compared with results seen in the control group. |
Exploratory analysis showed increased levels of Tregs, CD4⁺CD45RA⁺CD31⁺ naïve T-cells, and sjTRECs in the peripheral blood with MSCs vs control, confirming MSCs decrease the incidence and severity of cGvHD through the thymus pathway. |
These findings support MSCs as a viable treatment option for patients with SR-aGvHD, aiming to reduce the cGvHD burden and improve long-term survival outcomes. |
aGvHD, acute graft-versus-host disease; cGvHD, chronic graft-versus-host disease; CI, confidence interval; CRFS, cGvHD-free, relapse-free survival; HR, hazard ratio; MSC, mesenchymal stromal cell; sjTRECS, signal joint T-cell receptor excision DNA circles; SR-aGvHD, steroid-resistant aGvHD; Treg, T regulatory cells.
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