Reduced Incidence of Severe Hemorrhagic Cystitis in Prophylaxis Infusion of Mensenchymal Stromal Cells for Gvhd, a Secondary Endpoints in a Randomized,Multiple Center Clinical Tria

Aim:MSCs are being explored for their potential to prevent and treat graft-versus-host disease (GVHD) in allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients. A secondary endpoint was anaylzed in our multi-center prospective randomized controlled study (ChiCTR1900022292) aimed to evaluate the efficacy of MSC infusions in preventing hemorrhagic cystitis (HC), a common complication of allo-HSCT.

Methods:Based on the electronic data capture（EDC) ,clinical data, interleukin levels, and T lymphocyte subgroups were monitored to identify potential biomarkers and risk factors for predicting HC occurrence.

Results:A total of 192 patients were included in the analysis, of whom 36 (18.8%) developed HC. The results showed both a lower incidence of HC and severe HC in the MSCs group compared to the control group. Factors associated with severe HC included BK virus infection, older age, and slower platelet reconstitution(Table 1). Combination of these risk factors had an area under the curve (AUC) of 0.756 (95% CI: 0.586-0.851), with a specificity (1-specificity) of 0.688(Figure 1). Cytokine and T cell subset analysis revealed decreased levels of IL-4, TNF-α, and TNF-γ in patients with severe HC, as well as increases in CD3+ T cells, CD4/CD8 ratio, and CD19+ B cells.

Conclusions:This trial demonstrated the potential of MSCs to prevent severe HC in allo-HSCT patients. The identified biomarkers and risk factors may help predict and manage the development of HC in this population.

Key words:Hemorrhagic Cystitis,Mensenchymal Stromal Cells,Clinical Trial,prophylaxis

No relevant conflicts of interest to declare.