Long-term follow-up for the microbiological safety of clinical microencapsulated neonatal porcine islet transplantation.

Enrollment in three clinical trials for microencapsulated neonatal porcine islet xenotransplantation to treat unstable type 1 diabetic patients concluded in November 2014. In this study, we report a long-term follow-up assessment of microbiological safety for these trials. Thirty-eight type 1 diabetic patients received microencapsulated neonatal porcine islet transplants. Islets were isolated and prepared from the pancreata of New Zealand (NZ) based designated pathogen-free (DPF) pigs under GMP conditions. Blood samples of thirty-six patients were collected from 5 to 7 years post-first transplant and were tested by real-time PCR for porcine circovirus-1 (PCV1), porcine circovirus-2 (PCV2), porcine lymphotropic herpesvirus 1 (PLHV1), porcine lymphotropic herpesvirus 2 (PLHV2), and porcine cytomegalovirus (PCMV). To detect porcine endogenous retrovirus (PERV), specific real-time PCR and product enhanced reserve transcriptase (PERT) assays were performed. PCV1, PCV2, PLHV1, PLHV2, PCMV, PERV, and reverse transcriptase (RT) activity remained undetected in all tested samples indicating no viral transmission. Except for one patient that died due to complications unrelated to the transplant, there were no significant adverse events. Microbiological safety was demonstrated for microencapsulated neonatal porcine islet xenotransplantation from 5-7 years post-transplantation consistent with earlier reports.

Level of acceptance of islet cell and kidney xenotransplants by personnel of hospitals with and without experience in clinical xenotransplantation.

BACKGROUND: Recently, significant progress in both safety and efficacy has been achieved in the field of xenotransplantation, as exemplified by results from the first clinical trials of porcine islet transplantation. It would be of interest to learn whether the attitude of the clinical staff involved in such trials changes as the trials are carried out in their own hospital. METHODS: One hundred and four clinical staff members from the Eva Peron Hospital of San Martin (Buenos Aires, Argentina) where clinical trials of islet xenotransplantation have been performed and 92 similar staff members from the Diego Thompson Hospital (Buenos Aires, Argentina) where no such xenotransplantation has been carried out participated in the study. Data were collected anonymously using questionnaires. RESULTS: Statistically significant differences between the acceptance of xenotransplantation by clinical personnel in a hospital that had carried out clinical xenotransplantation trials were observed when compared with the acceptance of a similar staff from the hospital that had not carried out such trials. CONCLUSION: This study shows that involvement in clinical xenotransplantation trials significantly changes the attitude of the clinical staff towards this technology and suggests that better information given to the society may increase acceptance of the xenotransplantation.