1. Orive, G. et al. Engineering a Clinically Translatable Bioartificial Pancreas to Treat Type I Diabetes. Trends in Biotechnology 36, 445–456 (2018).
2. Klymiuk, N., Ludwig, B., Seissler, J., Reichart, B. & Wolf, E. Current Concepts of Using Pigs as a Source for Beta-Cell Replacement Therapy of Type 1 Diabetes. Curr Mol Bio Rep 2, 73–82 (2016).
3. Colton, C. K. Oxygen supply to encapsulated therapeutic cells. Adv Drug Deliv Rev 67–68, 93–110 (2014).
4. Dulong, J.-L. & Legallais, C. A theoretical study of oxygen transfer including cell necrosis for the design of a bioartificial pancreas. Biotechnol Bioeng 96, 990–998 (2007).
5. Barkai, U., Rotem, A. & de Vos, P. Survival of encapsulated islets: More than a membrane story. World J Transplant 6, 69–90 (2016).
6. Avgoustiniatos, E. S. & Colton, C. K. Effect of external oxygen mass transfer resistances on viability of immunoisolated tissue. Ann N Y Acad Sci 831, 145–167 (1997).
7. Komatsu, H., Kandeel, F. & Mullen, Y. Impact of Oxygen on Pancreatic Islet Survival. Pancreas 47, 533–543 (2018).
8. Moritz, W. et al. Apoptosis in hypoxic human pancreatic islets correlates with HIF-1alpha expression. FASEB J 16, 745–747 (2002).
9. Carlsson, P. O., Palm, F., Andersson, A. & Liss, P. Markedly decreased oxygen tension in transplanted rat pancreatic islets irrespective of the implantation site. Diabetes 50, 489–495 (2001).
10. Vériter, S. et al. The impact of hyperglycemia and the presence of encapsulated islets on oxygenation within a bioartificial pancreas in the presence of mesenchymal stem cells in a diabetic Wistar rat model. Biomaterials 32, 5945–5956 (2011).
11. Vériter, S. et al. Improvement of subcutaneous bioartificial pancreas vascularization and function by coencapsulation of pig islets and mesenchymal stem cells in primates. Cell Transplant 23, 1349–1364 (2014).
12. Iwata, H., Arima, Y. & Tsutsui, Y. Design of Bioartificial Pancreases From the Standpoint of Oxygen Supply. Artif Organs 42, E168–E185 (2018).
13. Jones, G. L. et al. Time course and quantification of pancreatic islet revascularization following intraportal transplantation. Cell Transplant 16, 505–516 (2007).
14. Dionne, K. E., Colton, C. K. & Yarmush, M. L. Effect of hypoxia on insulin secretion by isolated rat and canine islets of Langerhans. Diabetes 42, 12–21 (1993).
15. Rodriguez-Brotons, A. et al. Impact of Pancreatic Rat Islet Density on Cell Survival during Hypoxia. J Diabetes Res 2016, 3615286 (2016).
16. Paredes-Juarez, G. A. et al. DAMP production by human islets under low oxygen and nutrients in the presence or absence of an immunoisolating-capsule and necrostatin-1. Sci Rep 5, 14623 (2015).
17. Brandhorst, D., Brandhorst, H., Mullooly, N., Acreman, S. & Johnson, P. R. V. High Seeding Density Induces Local Hypoxia and Triggers a Proinflammatory Response in Isolated Human Islets. Cell Transplant 25, 1539–1546 (2016).
18. Fisher, R. Johnson, A.S., R.J. Fisher, G.C. Weir and C.K. Colton, “Oxygen Consumption and Diffusion in Assemblages of Respiring Spheres: Performance Enhancement of a Bio-artificial Pancreas”, Chem. Eng. Sci, Vol.64, No.22, 4470-87, (2009). (2009).
19. Barton, F. B. et al. Improvement in outcomes of clinical islet transplantation: 1999-2010. Diabetes Care 35, 1436–1445 (2012).
20. Emamaullee, J. A., Shapiro, A. M. J., Rajotte, R. V., Korbutt, G. & Elliott, J. F. Neonatal porcine islets exhibit natural resistance to hypoxia-induced apoptosis. Transplantation 82, 945–952 (2006).
21. Pepper, A. R. et al. A prevascularized subcutaneous device-less site for islet and cellular transplantation. Nat Biotechnol 33, 518–523 (2015).
22. Trivedi, N., Steil, G. M., Colton, C. K., Bonner-Weir, S. & Weir, G. C. Improved vascularization of planar membrane diffusion devices following continuous infusion of vascular endothelial growth factor. Cell Transplant 9, 115–124 (2000).
23. Johnson, A. S. et al. Quantitative assessment of islets of Langerhans encapsulated in alginate. Tissue Eng Part C Methods 17, 435–449 (2011).
24. Mouré, A. et al. Extracellular hemoglobin combined with an O2-generating material overcomes O2 limitation in the bioartificial pancreas. Biotechnology and bioengineering 116, 1176–1189 (2019).
25. Barkai, U. et al. Enhanced oxygen supply improves islet viability in a new bioartificial pancreas. Cell Transplant 22, 1463–1476 (2013).
26. McQuilling, J. P., Sittadjody, S., Pendergraft, S., Farney, A. C. & Opara, E. C. Applications of particulate oxygen-generating substances (POGS) in the bioartificial pancreas. Biomater Sci 5, 2437–2447 (2017).
27. Pedraza, E., Coronel, M. M., Fraker, C. A., Ricordi, C. & Stabler, C. L. Preventing hypoxia-induced cell death in beta cells and islets via hydrolytically activated, oxygen-generating biomaterials. Proc Natl Acad Sci U S A 109, 4245–4250 (2012).
28. Evron, Y. et al. Long-term viability and function of transplanted islets macroencapsulated at high density are achieved by enhanced oxygen supply. Sci Rep 8, 6508 (2018).
29. Mandenius, C.-F. & Brundin, A. Bioprocess optimization using design-of-experiments methodology. Biotechnology Progress 24, 1191–1203 (2008).
30. Rodriguez-Brotons, A. et al. Comparison of Perfluorodecalin and HEMOXCell as Oxygen Carriers for Islet Oxygenation in an In Vitro Model of Encapsulation. Tissue Eng Part A 22, 1327–1336 (2016).
31. Le Pape, F. et al. HEMOXCell, a New Oxygen Carrier Usable as an Additive for Mesenchymal Stem Cell Culture in Platelet Lysate-Supplemented Media. Artif Organs 41, 359–371 (2017).
32. Graham, M. L., Bellin, M. D., Papas, K. K., Hering, B. J. & Schuurman, H.-J. Species incompatibilities in the pig-to-macaque islet xenotransplant model affect transplant outcome: a comparison with allotransplantation. Xenotransplantation 18, 328–342 (2011).
33. Mueller, K. R. et al. Differences in glucose-stimulated insulin secretion in vitro of islets from human, nonhuman primate, and porcine origin. Xenotransplantation 20, 75–81 (2013).
34. Papas, K. K. et al. Human islet oxygen consumption rate and DNA measurements predict diabetes reversal in nude mice. Am J Transplant 7, 707–713 (2007).
35. Sweet, I. R. et al. Glucose-stimulated increment in oxygen consumption rate as a standardized test of human islet quality. Am J Transplant 8, 183–192 (2008).
36. Kitzmann, J. P. et al. Real-time assessment of encapsulated neonatal porcine islets prior to clinical xenotransplantation. Xenotransplantation 19, 333–336 (2012).
37. Ma, Z., Moruzzi, N., Catrina, S.-B., Grill, V. & Björklund, A. Hyperoxia inhibits glucose-induced insulin secretion and mitochondrial metabolism in rat pancreatic islets. Biochem Biophys Res Commun 443, 223–228 (2014).
38. Forget, A. et al. Oxygen-Releasing Coatings for Improved Tissue Preservation. ACS Biomater. Sci. Eng. 3, 2384–2390 (2017).
39. Samy, K. P., Martin, B. M., Turgeon, N. A. & Kirk, A. D. Islet cell xenotransplantation: a serious look toward the clinic. Xenotransplantation 21, 221–229 (2014).
40. De Mesmaeker, I. et al. Increase Functional β-Cell Mass in Subcutaneous Alginate Capsules With Porcine Prenatal Islet Cells but Loss With Human Adult Islet Cells. Diabetes 67, 2640–2649 (2018).
41. Kin, T. & Korbutt, G. S. Delayed functional maturation of neonatal porcine islets in recipients under strict glycemic control. Xenotransplantation 14, 333–338 (2007).
42. Li, W.-C. et al. Porcine Neonatal Pancreatic Cell Clusters Maintain Their Multipotency in Culture and After Transplantation. Sci Rep 8, 8212 (2018).
43. Omer, A. et al. Survival and maturation of microencapsulated porcine neonatal pancreatic cell clusters transplanted into immunocompetent diabetic mice. Diabetes 52, 69–75 (2003).
44. Hakim, F. et al. High oxygen condition facilitates the differentiation of mouse and human pluripotent stem cells into pancreatic progenitors and insulin-producing cells. J Biol Chem 289, 9623–9638 (2014).
45. Heinis, M. et al. Oxygen tension regulates pancreatic beta-cell differentiation through hypoxia-inducible factor 1alpha. Diabetes 59, 662–669 (2010).
46. Coronel, M. M., Geusz, R. & Stabler, C. L. Mitigating hypoxic stress on pancreatic islets via in situ oxygen generating biomaterial. Biomaterials 129, 139–151 (2017).
47. Hadanny, A. & Efrati, S. The Hyperoxic-Hypoxic Paradox. Biomolecules 10, (2020).
48. Sörenby, A. K. et al. Preimplantation of an immunoprotective device can lower the curative dose of islets to that of free islet transplantation: studies in a rodent model. Transplantation 86, 364–366 (2008).
49. Mitchelson, F., Safley, S. A., Gordon, K., Weber, C. J. & Sambanis, A. Peritoneal dissolved oxygen and function of encapsulated adult porcine islets transplanted in streptozotocin diabetic mice. Xenotransplantation e12673 (2021) doi:10.1111/xen.12673.
50. Davalli, A. M. et al. Vulnerability of islets in the immediate posttransplantation period. Dynamic changes in structure and function. Diabetes 45, 1161–1167 (1996).
51. Emamaullee, J. A. & Shapiro, A. M. J. Factors Influencing the Loss of β-Cell Mass in Islet Transplantation. Cell Transplant 16, 1–8 (2007).
52. Mattsson, G., Jansson, L. & Carlsson, P.-O. Decreased vascular density in mouse pancreatic islets after transplantation. Diabetes 51, 1362–1366 (2002).
53. Cechin, S. et al. Influence of in vitro and in vivo oxygen modulation on β cell differentiation from human embryonic stem cells. Stem Cells Transl Med 3, 277–289 (2014).
54. Salama, A. et al. Neu5Gc and α1-3 GAL xenoantigen knockout does not affect glycemia homeostasis and insulin secretion in pigs. Diabetes 66, 987–993 (2017).
55. Manavella, D. D. et al. Two-step transplantation with adipose tissue-derived stem cells increases follicle survival by enhancing vascularization in xenografted frozen-thawed human ovarian tissue. Hum Reprod 33, 1107–1116 (2018).
56. Van Eyck, A.-S. et al. Electron paramagnetic resonance as a tool to evaluate human ovarian tissue reoxygenation after xenografting. Fertil Steril 92, 374–381 (2009).
57. Korbutt, G. S. et al. Large scale isolation, growth, and function of porcine neonatal islet cells. J Clin Invest 97, 2119–2129 (1996).
58. Miyazaki, J. et al. Establishment of a pancreatic beta cell line that retains glucose-inducible insulin secretion: special reference to expression of glucose transporter isoforms. Endocrinology 127, 126–132 (1990).
59. Ricordi, C. et al. Islet isolation assessment in man and large animals. Acta Diabetol Lat 27, 185–195 (1990).