107.4: International human xenotransplantation inventory: A 12-year follow-up

Background: Following the recommendations by a panel of experts gathered by the World Health Organization (WHO) in 2005, an inventory was established to collect practices of human xenotransplantation worldwide (www.humanxenotransplant.org). The website was activated in October 2006, in collaboration with the International Xenotransplantation Association (IXA) and the WHO. A first report on the collected xenotransplantation activities was published in 2010 in the journal Transplantation. We present here the update over the last 12 years. Methods: We collected information from publications in scientific journals, presentations at international congresses, the internet, and declarations of International Xenotransplantation Association members on xenotransplantation procedures in humans performed. Results: A total of 9 new applications of human xenotransplantation were identified, with pig as source animal in all applications. The procedures involved transplantation of islets of Langerhans, skin, cornea, choroid plexus cells, heart, and kidney. The treatments were performed in USA, China, New Zealand, and Argentina. Conclusion: Recently, several clinical applications of organ and cell xenotransplantation were initiated. Compared to the previous reported period (1995-2010, with 29 activities, mostly without governmental regulation), the recent number of clinical activities was reduced, and all were officially approved. This information should be used to inform healthcare officials, staff, and the public with the objective of encouraging good practices based on internationally harmonized guidelines driven by initiatives such as the Changsha Communiqué. References: 1. Sgroi A, Buhler LH, Morel P, Sykes M, Noel L. International human xenotransplantation inventory. Transplantation. Sep 27 2010;90(6):597-603. doi:10.1097/TP.0b013e3181eb2e8c 2. Matsumoto S, Tan P, Baker J, et al. Clinical Porcine Islet Xenotransplantation Under Comprehensive Regulation. Transplantation Proceedings. 2014/07/01/ 2014;46(6):1992-1995. 3. Wynyard S, Nathu D, Garkavenko O, Denner J, Elliott R. Microbiological safety of the first clinical pig islet xenotransplantation trial in New Zealand. Xenotransplantation. 2014;21(4):309-323. 4. Matsumoto S, Abalovich A, Wechsler C, Wynyard S, Elliott RB. Clinical Benefit of Islet Xenotransplantation for the Treatment of Type 1 Diabetes. EBioMedicine. 2016;12:255-262. 5. Morozov VA, Wynyard S, Matsumoto S, Abalovich A, Denner J, Elliott R. No PERV transmission during a clinical trial of pig islet cell transplantation. Virus Research. 2017/01/02/ 2017;227:34-40. 6. Zheng J, Huang X, Zhang Y, et al. Short-term results of acellular porcine corneal stroma keratoplasty for herpes simplex keratitis. Xenotransplantation. Jul 2019;26(4):e12509. doi:10.1111/xen.12509 7. Snow B, Mulroy E, Bok A, et al. A phase IIb, randomised, double-blind, placebo-controlled, dose-ranging investigation of the safety and efficacy of NTCELL((R)) [immunoprotected (alginate-encapsulated) porcine choroid plexus cells for xenotransplantation] in patients with Parkinson’s disease. Parkinsonism Relat Disord. Apr 2019;61:88-93. 8. Cooper DKC, Groth C-G. A Record of International Meetings on Xenotransplantation 1988–2010. Xenotransplantation. 2011;18(4):229-231. 9. Sykes M, Sandrin M, Cozzi E, Rees MA. World Health Organization resolution on xenotransplantation. Xenotransplantation. May 2004;11(3):224-5.