Chapters authored
Xenotransplantation for Islets from Clinical Side
Islet transplantation can eliminate severe hypoglycemia symptoms caused by conventional treatment, and has the advantages of less trauma and complications, which is considered as the most promising treatment for type 1 diabetes mellitus (T1DM). Regulatory guidance is needed for a standard pig source. In section 1, the regulation of medical grade designed pathogen free (DPF) donor pig for clinical xenotransplantation consists of five parts: genetic quality control, microbiological surveillance, formula feeds, specification of pathological diagnosis, and requirements of environment and housing facilities. In section 2, we present the current approach and progress in pig donor selecting, pancreatic digestion, isolation and preparation of porcine islet grafts, identification and quality assessment of final islet product in clinical trials. The liver is currently the most preferred site for islet transplantation, even though it is far from ideal. A large number of alternative sites have been used for islet transplantation in experimental animal models to provide improved engraftment and long-term survival. In Section 3, we introduce some commonly used sites in xenotransplantation. The benefits and drawbacks of each parameter above are discussed in an attempt to decide which is the most suitable for clinical use and to direct future research.
Part of the book: Xenotransplantation
Biosafety Barrier to Xenotransplantation
Biosafety barrier is most important for xenotransplantation clinical trial. Source animals used in xenotransplantation should be bred in a closed herd and raised in a well-controlled, pathogen-free environment with high standards of animal welfare. To ensure the source animals’ freedom from known pathogens under adequate biosecurity and surveillance, extensive tests must be done. Biosafety of DPF source pig should be proved by animal model before clinical trial. In addition, inclusion criteria for transplant recipients and clinical safe transplantation protocol should be established. Comprehensive anti-immune rejection treatment based on immune tolerance program can significantly prolong the xenograft survival and reduce the adverse impact on the immune system, which is suitable for clinical application. According to the clinical follow-up plan of the xenograft recipients, the patients should come back to the hospital for a check at regular intervals after the transplantation. The database of clinical trials for xenotransplantation should be established, including specimens, paper documents, and electronic documents. The information and samples of xenotransplantation donors and recipients should be preserved for long time.
Part of the book: Xenotransplantation