Browsing by Author "Stock, Peter G."

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    The demise of islet allotransplantation in the United States: A call for an urgent regulatory update
    (Wiley, 2021-04) Witkowski, Piotr; Philipson, Louis H.; Kaufman, Dixon B.; Ratner, Lloyd E.; Abouljoud, Marwan S.; Bellin, Melena D.; Buse, John B.; Kandeel, Fouad; Stock, Peter G.; Mulligan, David C.; Markmann, James F.; Kozlowski, Tomasz; Andreoni, Kenneth A.; Alejandro, Rodolfo; Baidal, David A.; Hardy, Mark A.; Wickrema, Amittha; Mirmira, Raghavendra G.; Fung, John; Becker, Yolanda T.; Josephson, Michelle A.; Bachul, Piotr J.; Pyda, Jordan S.; Charlton, Michael; Millis, J. Michael; Gaglia, Jason L.; Stratta, Robert J.; Fridell, Jonathan A.; Niederhaus, Silke V.; Forbes, Rachael C.; Jayant, Kumar; Robertson, R. Paul; Odorico, Jon S.; Levy, Marlon F.; Harland, Robert C.; Abrams, Peter L.; Olaitan, Oyedolamu K.; Kandaswamy, Raja; Wellen, Jason R.; Japour, Anthony J.; Desai, Chirag S.; Naziruddin, Bashoo; Balamurugan, Appakalai N.; Barth, Rolf N.; Ricordi, Camillo; Surgery, School of Medicine
    Islet allotransplantation in the United States (US) is facing an imminent demise. Despite nearly three decades of progress in the field, an archaic regulatory framework has stymied US clinical practice. Current regulations do not reflect the state-of-the-art in clinical or technical practices. In the US, islets are considered biologic drugs and “more than minimally manipulated” human cell and tissue products (HCT/Ps). In contrast, across the world, human islets are appropriately defined as “minimally manipulated tissue” and not regulated as a drug, which has led to islet allotransplantation (allo-ITx) becoming a standard-of-care procedure for selected patients with type 1 diabetes mellitus. This regulatory distinction impedes patient access to islets for transplantation in the US. As a result only 11 patients underwent allo-ITx in the US between 2016 and 2019, and all as investigational procedures in the settings of a clinical trials. Herein, we describe the current regulations pertaining to islet transplantation in the United States. We explore the progress which has been made in the field and demonstrate why the regulatory framework must be updated to both better reflect our current clinical practice and to deal with upcoming challenges. We propose specific updates to current regulations which are required for the renaissance of ethical, safe, effective, and affordable allo-ITx in the United States.
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    First World Consensus Conference on pancreas transplantation: Part II - recommendations
    (Wiley, 2021) Boggi, Ugo; Vistoli, Fabio; Andres, Axel; Arbogast, Helmut P.; Badet, Lionel; Baronti, Walter; Bartlett, Stephen T.; Benedetti, Enrico; Branchereau, Julien; Burke, George W., III; Buron, Fanny; Caldara, Rossana; Cardillo, Massimo; Casanova, Daniel; Cipriani, Federica; Cooper, Matthew; Cupisti, Adamasco; Davide, Josè; Drachenberg, Cinthia; de Koning, Eelco J. P.; Ettorre, Giuseppe Maria; Fernandez Cruz, Laureano; Fridell, Jonathan A.; Friend, Peter J.; Furian, Lucrezia; Gaber, Osama A.; Gruessner, Angelika C.; Gruessner, Rainer W. G.; Gunton, Jenny E.; Han, Duck-Jong; Iacopi, Sara; Kauffmann, Emanuele Federico; Kaufman, Dixon; Kenmochi, Takashi; Khambalia, Hussein A.; Lai, Quirino; Langer, Robert M.; Maffi, Paola; Marselli, Lorella; Menichetti, Francesco; Miccoli, Mario; Mittal, Shruti; Morelon, Emmanuel; Napoli, Niccolò; Neri, Flavia; Oberholzer, Jose; Odorico, Jon S.; Öllinger, Robert; Oniscu, Gabriel; Orlando, Giuseppe; Ortenzi, Monica; Perosa, Marcelo; Perrone, Vittorio Grazio; Pleass, Henry; Redfield, Robert R.; Ricci, Claudio; Rigotti, Paolo; Robertson, R. Paul; Ross, Lainie F.; Rossi, Massimo; Saudek, Frantisek; Scalea, Joseph R.; Schenker, Peter; Secchi, Antonio; Socci, Carlo; Sousa Silva, Donzilia; Squifflet, Jean Paul; Stock, Peter G.; Stratta, Robert J.; Terrenzio, Chiara; Uva, Pablo; Watson, Christopher J. E.; White, Steven A.; Marchetti, Piero; Kandaswamy, Raja; Berney, Thierry; Surgery, School of Medicine
    The First World Consensus Conference on Pancreas Transplantation provided 49 jury deliberations regarding the impact of pancreas transplantation on the treatment of diabetic patients, and 110 experts' recommendations for the practice of pancreas transplantation. The main message from this consensus conference is that both simultaneous pancreas-kidney transplantation (SPK) and pancreas transplantation alone can improve long-term patient survival, and all types of pancreas transplantation dramatically improve the quality of life of recipients. Pancreas transplantation may also improve the course of chronic complications of diabetes, depending on their severity. Therefore, the advantages of pancreas transplantation appear to clearly surpass potential disadvantages. Pancreas after kidney transplantation increases the risk of mortality only in the early period after transplantation, but is associated with improved life expectancy thereafter. Additionally, preemptive SPK, when compared to SPK performed in patients undergoing dialysis, appears to be associated with improved outcomes. Time on dialysis has negative prognostic implications in SPK recipients. Increased long-term survival, improvement in the course of diabetic complications, and amelioration of quality of life justify preferential allocation of kidney grafts to SPK recipients. Audience discussions and live voting are available online at the following URL address: http://mediaeventi.unipi.it/category/1st-world-consensus-conference-of-pancreas-transplantation/246.