PMC:6141714 / 17492-19882
Annnotations
{"target":"http://pubannotation.org/docs/sourcedb/PMC/sourceid/6141714","sourcedb":"PMC","sourceid":"6141714","source_url":"https://www.ncbi.nlm.nih.gov/pmc/6141714","text":"Based on timing of onset after HSCT and according to the clinical manifestations observed, GvHD can be classified as acute or chronic. Acute GvHD usually affects the skin, liver and gastrointestinal tract of the patients affected by the disease (167). On the other hand, chronic GvHD can affect any organ (168). Clinical effects commonly observed after the administration of hMSCs included an increase in the survival rates (35, 36, 39–41, 44, 45, 48, 49, 51, 56–62, 65–68, 71, 72), a decrease in the severity of the symptoms of the disease (33–36, 38–46, 52–59, 61–64, 66–68, 71) and a reduction in the incidence of acute and chronic GvHD (51, 53, 54, 65) in patients submitted to hematopoietic stem cell transplantation. Among the studies conducted in mice, the cumulative survival rate, the clinical score of the disease and the rate of change in body weight were the outcomes used by most animal studies selected in this systematic review to assess the potential of hMSCs administration for the treatment of GvHD. Among the human clinical trials selected, the primary endpoints used by most studies to assess the effectiveness of the treatment with hMSCs were: the overall survival rate; the disease-free survival rate; the progression-free survival rate; the non-relapse mortality rate; and the relapse incidence. We propose that both the disease-free survival rate and the progression-free survival rate are the most appropriate endpoints for future clinical trials when evaluating the effectiveness of hMSCs administration for the treatment of GvHD. While the disease-free survival rate should be used for patients in remission at time of HSCT, the progression-free survival rate should be used for patients that were not in remission at time of HSCT. These two primary endpoints were chosen because they are more likely to not be affected by bias, are detected earlier than the overall survival rate, include all clinically important events evaluated, and are more likely to reflect the real benefits of the treatment. Furthermore, additional endpoints such as the cumulative incidence of grade II-IV acute GVHD, the cumulative incidence of grade III-IV acute GVHD, and the cumulative incidence of moderate or severe chronic GVHD can also be used in combination with the primary endpoints selected in order to answer to other important questions about the benefits of the 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