膵島移植症例登録報告（2021）

抄録

The Phase Ⅱ study, a multicenter clinical trial of islet transplantation in Japan using anti-thymocyte globulin induction, was started in 2012. In the first islet transplantation anti-thymocyte globulin was used as induction therapy and in the second and third islet transplantation if needed, Anti CD 25 antibody was used as induction therapy. Calcineurin inhibitors and mycophenolate mofetil were used as maintenance immunosuppressive therapy. The primary endpoint of this clinical trial was the proportion of subjects with HbA1c levels less than 7.4% and who are free of severe hypoglycemic events from day 90 to one year after the first islet cell infusion. As the result of the interim analysis of this clinical study, the primary endpoint of this study to keep HbA1c level less than 7.4% was achieved with 75% of the patients with no episode of severe hypoglycemia as well. And islet graft survival remained better than in the previous era, so far with about 80% at 4 years after islet transplantation. Additionally, there was no surgical complication when the islet cells were infused. In April 2020, according to these successful results of the clinical trial, islet transplantation was covered by health insurance in Japan.