Although mesenchymal stromal cells (MSCs) possess immunomodulatory properties and exhibit\npromising efficacy against chronic graft-versus-host disease (cGVHD), little is known about the\nefficacy of MSCs in the prophylaxis of cGVHD after HLA-haploidentical hematopoietic stem-cell\ntransplantation (HLA-haplo HSCT).\nPatients and Methods\nIn this multicenter, double-blind, randomized controlled trial, we investigated the incidence and\nseverity of cGVHD among patients, and the changes in T, B, and natural killer (NK) cells after the\nrepeated infusion of MSCs.\nResults\nThe 2-year cumulative incidence of cGVHD in the MSCs group was 27.4% (95% CI, 16.2% to\n38.6%), compared with 49.0% (95% CI, 36.5% to 61.5%) in the non-MSCs control group (P = .021).\nSeven patients in the non-MSCs control group had severe lung cGVHD, but no patients in the MSCs\ngroup developed typical lung cGVHD (P = .047). After the MSC infusions, increasing memory\nB lymphocytes and regulatory T cells, as well as the ratio of type 1 T helper to type 2 T helper cells,\nwere observed, whereas the number of NK cells decreased.\nConclusion\nOur findings suggest that the repeated infusion of MSCs might inhibit cGVHD symptoms in patients\nafter HLA-haplo HSCT, accompanied by changes in the numbers and subtypes of T, B, and NK cells,\nleading to the acquisition of immune tolerance.
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