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MSC infusion for GvHD prophylaxis post haplo-HSCT
Multipotent MSCs possess strong immunomodulatory properties and have shown promise in reducing GvHD when administered 45 to 100 days post haplo-HSCT, although some patients still experienced cGvHD. A phase IV, multicenter, randomized clinical trial (ChiCTR1900022292) was initiated to evaluate the efficacy and safety of early MSC infusions for the prophylaxis of aGvHD and cGvHD simultaneously. Patients were recruited between 2019 and 2023 at three hospitals in China and received umbilical cord MSCs (administered at 1 × 106/kg four hours before the commencement of Day 0, once weekly for the first month after HSCT, once every 2 weeks for the second month, and once during the third month) for a total of eight doses. The primary endpoint was cumulative incidence of severe cGvHD at 2 years. In total, 192 patients were enrolled and randomized to MSC or control, with results published by Yao et al. in the Journal of Clinical Oncology.
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Key learnings2 |
Estimated 2-year cumulative incidence of severe cGvHD and all grades of cGvHD were lower in the MSC group vs the control group (5.5% vs 14.8%, p = 0.33 for severe, and 27.6% vs 45.5%, p = 0.22 for all grades cGvHD). |
Significantly fewer patients treated with MSC developed aGvHD vs control (17.7% vs 47.9% cumulative incidence, p < 0.001). Analysis of specific lesions showed significant differences in aGvHD in the liver (p = 0.010), skin (p = 0.023), upper small intestine (p = 0.024), and lower small intestine (p = 0.001). |
The 3-year GRFS rate was 62.4% in the MSC group vs 32.0% in the control group (p > 0.001). The most common AEs during the transplantation period were Epstein Barr virus reactivation (45.8%) and cytomegalovirus reactivation (44.3%). In total, two deaths occurred. |
Infusion of MSCs within 3 months post haplo-HSCT led to significant reductions in aGvHD and cGvHD incidence and severity. Further investigation into combination prophylactic strategies including MSCs and MSC infusion dose and timing could improve patient outcomes. |
Abbreviations: AE, adverse event; aGvHD, acute graft-versus-host disease; cGvHD, chronic graft-versus-host disease; GRFS, graft-versus-host disease relapse-free survival; haplo-HSCT, haploidentical hematopoietic stem cell transplantation; MSC, mesenchymal stromal cell.
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