Patients' opinions 10 years after receiving encapsulated porcine islet xenotransplantation without immunosuppression.

Abstract

Background: Previously we performed clinical encapsulated neonatal porcine islet transplantation under comprehensive regulation, and demonstrated the efficacy and safety. To analyze the patients' quality of life (QOL), we assessed patients' opinions 10 years after islet xenotransplantation.

Methods: Twenty-one type 1 diabetic patients received microencapsulated neonatal porcine islet transplants in Argentina were enrolled. Seven patients were enrolled in efficacy and safety study and 14 patients were enrolled in safety studies. Patients' opinions related to the current and pre-transplant status of diabetes control, blood glucose levels, severe hypoglycemia, and hyperglycemia required hospitalization were analyzed. In addition, opinions related to islet xenotransplantation were assessed.

Results: At the time of this survey, average HbA1c was still significantly lower compared to pre-transplantation (8.5 ± 0.9 (%) at pre-transplant and 7.4 ± 0.5(%) at the survey, p < .05) and average insulin dose were also lower (0.95 ± 0.32 (IU/kg) at pre-transplant and 0.73 ± 0.27 (IU) at the survey). The majority of patients improved diabetes control (71%), blood glucose levels (76%), severe hypoglycemia (86%) and hyperglycemia required hospitalization (76%), and no patients deteriorated in all of the categories when compared with pre-transplantation. No patients had cancer, or psychological problem, and one patient had a serious adverse event. The majority of patients wanted to recommend this treatment to other patients (76%) and receive booster transplantation (85.7%).

Conclusions: The majority of patients had positive opinions related to the encapsulated porcine islet xenotransplantation 10 years after transplantation.