Vos T, Lim SS, Abbafati C, Abbas KM, Abbasi M, Abbasifard M, et al. Global burden of 369 diseases and injuries in 204 countries and territories, 1990–2019: a systematic analysis for the global burden of Disease Study 2019. Lancet. 2020;396(10258):1204–22.
Cho NH, Shaw J, Karuranga S, Huang Y, da Rocha Fernandes J, Ohlrogge A, et al. IDF Diabetes Atlas: global estimates of diabetes prevalence for 2017 and projections for 2045. Diabetes Res Clin Pract. 2018;138:271–81.
Moghbeli M, Naghibzadeh B, Ghahraman M, Fatemi S, Taghavi M, Vakili R, et al. Mutations in HNF1A gene are not a Common cause of familial young-onset diabetes in Iran. Indian J Clin Biochem. 2018;33(1):91–5.
Akhlaghipour I, Bina AR, Mogharrabi MR, Fanoodi A, Ebrahimian AR, Khojasteh Kaffash S, et al. Single-nucleotide polymorphisms as important risk factors of diabetes among Middle East population. Hum Genomics. 2022;16(1):11.
Moghbeli M, Khedmatgozar H, Yadegari M, Avan A, Ferns GA, Ghayour Mobarhan M. Cytokines and the immune response in obesity-related disorders. Adv Clin Chem. 2021;101:135–68.
Eizirik DL, Pasquali L, Cnop M. Pancreatic β-cells in type 1 and type 2 diabetes mellitus: different pathways to failure. Nat Reviews Endocrinol. 2020;16(7):349–62.
Siqueira ISLd, Alves Guimarães R, Mamed SN, Santos TAP, Rocha SD, Pagotto V, et al. Prevalence and risk factors for self-report diabetes mellitus: a population-based study. Int J Environ Res Public Health. 2020;17(18):6497.
Free radical research.
Zhu B, Qu S. The relationship between diabetes mellitus and cancers and its underlying mechanisms. Front Endocrinol. 2022;13:800995.
Mojarrad M, Moghbeli M. Genetic and molecular biology of bladder cancer among Iranian patients. Mol Genet Genomic Med. 2020;8(6):e1233.
Moghbeli M. Genetic and molecular biology of breast cancer among Iranian patients. J Transl Med. 2019;17(1):218.
Abbaszadegan MR, Moghbeli M. Genetic and molecular origins of colorectal Cancer among the iranians: an update. Diagn Pathol. 2018;13(1):97.
Kim I. A brief overview of cell therapy and its product. J Korean Association Oral Maxillofacial Surg. 2013;39(5):201.
Mount NM, Ward SJ, Kefalas P, Hyllner J. Cell-based therapy technology classifications and translational challenges. Philosophical Trans Royal Soc B: Biol Sci. 2015;370(1680):20150017.
El-Kadiry AE-H, Rafei M, Shammaa R. Cell therapy: types, regulation, and clinical benefits. Front Med. 2021;8:756029.
Squifflet J-P, Gruessner R, Sutherland D. The history of pancreas transplantation: past, present and future. Acta Chir Belg. 2008;108(3):367–78.
Parums DV. First Regulatory approval for allogeneic pancreatic islet Beta cell infusion for adult patients with type 1 diabetes Mellitus. Med Sci Monitor: Int Med J Experimental Clin Res. 2023;29:e941918–1.
Yang L, Hu Z-M, Jiang F-X, Wang W. Stem cell therapy for insulin-dependent diabetes: are we still on the road? World J Stem Cells. 2022;14(7):503.
Affan M, Dar MS. Donislecel-the first approved pancreatic islet cell therapy medication for type 1 diabetes: a letter to the editor. Ir J Med Sci (1971-). 2023:1–2.
Harris E. FDA greenlights first cell therapy for adults with type 1 diabetes. JAMA. 2023.
Soon-Shiong P, Heintz R, Merideth N, Yao Q, Yao Z, Zheng T, et al. Insulin independence in a type 1 diabetic patient after encapsulated islet transplantation. Lancet (London England). 1994;343(8903):950–1.
Calafiore R, Basta G, Luca G, Lemmi A, Montanucci MP, Calabrese G, et al. Microencapsulated pancreatic islet allografts into nonimmunosuppressed patients with type 1 diabetes: first two cases. Diabetes Care. 2006;29(1):137–8.
Tuch BE, Keogh GW, Williams LJ, Wu W, Foster JL, Vaithilingam V, et al. Safety and viability of microencapsulated human islets transplanted into diabetic humans. Diabetes Care. 2009;32(10):1887–9.
Weng L, Wang X, Liu H, Yu Z, Liu S. Light-responsive microneedle array with tunable insulin release function for painless and on-demand anti-diabetic therapy. Mater Lett. 2023:135684.
Okcu A, Yazir Y, Şimşek T, Mert S, Duruksu G, Öztürk A, et al. Investigation of the effect of pancreatic decellularized matrix on encapsulated islets of Langerhans with mesenchymal stem cells. Tissue Cell. 2023;82:102110.
Khaliq T, Sohail M, Minhas MU, Mahmood A, Munir A, Qalawlus AHM, et al. Hyaluronic acid/alginate-based biomimetic hydrogel membranes for accelerated diabetic wound repair. Int J Pharm. 2023;643:123244.
Kuwabara R, Qin T, Llacua LA, Hu S, Boekschoten MV, de Haan BJ, et al. Extracellular matrix inclusion in immunoisolating alginate-based microcapsules promotes longevity, reduces fibrosis, and supports function of islet allografts in vivo. Acta Biomater. 2023;158:151–62.
Kirk K, Hao E, Lahmy R, Itkin-Ansari P. Human embryonic stem cell derived islet progenitors mature inside an encapsulation device without evidence of increased biomass or cell escape. Stem cell Res. 2014;12(3):807–14.
Dufrane D, van Steenberghe M, Goebbels R-M, Saliez A, Guiot Y, Gianello P. The influence of implantation site on the biocompatibility and survival of alginate encapsulated pig islets in rats. Biomaterials. 2006;27(17):3201–8.
Pullen LC. Stem cell–derived pancreatic progenitor cells have now been transplanted into patients: report from IPITA 2018. Wiley Online Library; 2018. pp. 1581–2.
Dang HP, Chen H, Dargaville TR, Tuch BE. Cell delivery systems: toward the next generation of cell therapies for type 1 diabetes. J Cell Mol Med. 2022;26(18):4756–67.
Viacyte. ViaCyte and gore enter clinical phase agreement based on novel membrane technology for PEC-encap product candidate. 2020.
Viacyte. viacyte announces initiation of phase 2 study of encapsulated cell therapy for type 1 diabetes patients 2021 2021. https://viacyte.com/press-releases/viacyte‐announces‐initiation‐of‐phase‐2‐study‐of‐encapsulated‐cell‐ther‐apy‐for‐type‐1‐diabetes‐patients/.
Hodgson J. Drug pipeline 3Q23—ERT, bispecifics and CRISPR in sickle cell disease. Nat Biotechnol. 2023;41(11):1498–500.
Pagliuca F. Pre-clinical proof-of-Concept in two lead programs in type 1 diabetes. International Socety for Stem Cell Research; 2019.
Jones PM, Persaud SJ. β-cell replacement therapy for type 1 diabetes: closer and closer. Diabet Med. 2022;39(6).
Carlsson P-O, Espes D, Sedigh A, Rotem A, Zimerman B, Grinberg H, et al. Transplantation of macroencapsulated human islets within the bioartificial pancreas βAir to patients with type 1 diabetes mellitus. Am J Transplant. 2018;18(7):1735–44.
Ludwig B, Zimerman B, Steffen A, Yavriants K, Azarov D, Reichel A, et al. A novel device for islet transplantation providing immune protection and oxygen supply. Horm Metab Res. 2010;42(13):918–22.
Evron Y, Colton CK, Ludwig B, Weir GC, Zimermann B, Maimon S, et al. Long-term viability and function of transplanted islets macroencapsulated at high density are achieved by enhanced oxygen supply. Sci Rep. 2018;8(1):6508.
Cao R, Avgoustiniatos E, Papas K, de Vos P, Lakey JR. Mathematical predictions of oxygen availability in micro-and macro‐encapsulated human and porcine pancreatic islets. J Biomedical Mater Res Part B: Appl Biomaterials. 2020;108(2):343–52.
Gala-Lopez B, Pepper A, Dinyari P, Malcolm A, Kin T, Pawlick L, et al. Subcutaneous clinical islet transplantation in a prevascularized subcutaneous pouch–preliminary experience. CellR4. 2016;4(5):e2132.
Sernova Corp Presents Positive Preliminary. Safety and Efficacy Data in its Phase I/II Clinical Trial for Type-1 Diabetes: Biospace. https://www.biospace.com/article/sernova‐corp‐presents‐positive‐preliminary‐safety‐and‐efficacy‐data‐in‐its‐phase‐i‐ii‐clinical‐trial‐for‐type‐1‐diabetes/.
Bachul PJ, Perez-Gutierrez A, Juengel B, Golab K, Basto L, Perea L et al. 306-OR: modified approach for improved isllotransplantation into prevascularized sernova cell pouch device: preliminary results of the phase i/ii clinical trial at University of Chicago. Diabetes. 2022;71(Supplement_1).
Vegas AJ, Veiseh O, Doloff JC, Ma M, Tam HH, Bratlie K, et al. Combinatorial hydrogel library enables identification of materials that mitigate the foreign body response in primates. Nat Biotechnol. 2016;34(3):345–52.
Vegas AJ, Veiseh O, Gürtler M, Millman JR, Pagliuca FW, Bader AR, et al. Long-term glycemic control using polymer-encapsulated human stem cell–derived beta cells in immune-competent mice. Nat Med. 2016;22(3):306–11.
Shapiro AD, Konkle BA, Croteau SE, Miesbach WA, Hay CRM, Kazmi R, et al. First-in-human phase 1/2 clinical trial of SIG-001, an innovative shielded cell therapy platform, for hemophilia Α. Blood. 2020;136:8.
Taraballi F, Sushnitha M, Tsao C, Bauza G, Liverani C, Shi A, et al. Biomimetic tissue engineering: tuning the immune and inflammatory response to implantable biomaterials. Adv Healthc Mater. 2018;7(17):1800490.
Yesilyurt V, Veiseh O, Doloff JC, Li J, Bose S, Xie X, et al. A facile and versatile method to endow biomaterial devices with zwitterionic surface coatings. Adv Healthc Mater. 2017;6(4):1601091.
Liu Q, Chiu A, Wang L-H, An D, Zhong M, Smink AM, et al. Zwitterionically modified alginates mitigate cellular overgrowth for cell encapsulation. Nat Commun. 2019;10(1):5262.
Noverraz F, Montanari E, Pimenta J, Szabó L, Ortiz D, Gonelle-Gispert C, et al. Antifibrotic effect of ketoprofen-grafted alginate microcapsules in the transplantation of insulin producing cells. Bioconjug Chem. 2018;29(6):1932–41.
Jeon SI, Jeong J-H, Kim JE, Haque MR, Kim J, Byun Y, et al. Synthesis of PEG-dendron for surface modification of pancreatic islets and suppression of the immune response. J Mater Chem B. 2021;9(11):2631–40.
Derakhshankhah H, Sajadimajd S, Jahanshahi F, Samsonchi Z, Karimi H, Hajizadeh-Saffar E, et al. Immunoengineering Biomaterials in Cell-based therapy for type 1 diabetes. Tissue Eng Part B: Reviews. 2022;28(5):1053–66.
Piemonti L, Maffi P, Nano R, Bertuzzi F, Melzi R, Mercalli A, et al. Treating diabetes with islet transplantation: lessons from the Milan experience. Transplantation, Bioengineering, and regeneration of the endocrine pancreas. Elsevier; 2020. pp. 645–58.
Azzi J, Tang L, Moore R, Tong R, El Haddad N, Akiyoshi T, et al. Polylactide-cyclosporin A nanoparticles for targeted immunosuppression. FASEB J. 2010;24(10):3927.
Chen X, Liu H, Li H, Cheng Y, Yang L, Liu Y. In vitro expansion and differentiation of rat pancreatic duct-derived stem cells into insulin secreting cells using a dynamic three-dimensional cell culture system. Genet Mol Res. 2016;15(2).
Becker MW, Simonovich JA, Phelps EA. Engineered microenvironments and microdevices for modeling the pathophysiology of type 1 diabetes. Biomaterials. 2019;198:49–62.
Graham JG, Zhang X, Goodman A, Pothoven K, Houlihan J, Wang S, et al. PLG scaffold delivered antigen-specific regulatory T cells induce systemic tolerance in autoimmune diabetes. Tissue Eng Part A. 2013;19(11–12):1465–75.
Izadi Z, Hajizadeh-Saffar E, Hadjati J, Habibi-Anbouhi M, Ghanian MH, Sadeghi-Abandansari H, et al. Tolerance induction by surface immobilization of Jagged-1 for immunoprotection of pancreatic islets. Biomaterials. 2018;182:191–201.
McHugh MD, Park J, Uhrich R, Gao W, Horwitz DA, Fahmy TM. Paracrine co-delivery of TGF-β and IL-2 using CD4-targeted nanoparticles for induction and maintenance of regulatory T cells. Biomaterials. 2015;59:172–81.
Chen H, Teramura Y, Iwata H. Co-immobilization of urokinase and thrombomodulin on islet surfaces by poly (ethylene glycol)-conjugated phospholipid. J Controlled Release. 2011;150(2):229–34.
Su J, Hu B-H, Lowe WL Jr, Kaufman DB, Messersmith PB. Anti-inflammatory peptide-functionalized hydrogels for insulin-secreting cell encapsulation. Biomaterials. 2010;31(2):308–14.
Dong H, Fahmy TM, Metcalfe SM, Morton SL, Dong X, Inverardi L, et al. Immuno-isolation of pancreatic islet allografts using pegylated nanotherapy leads to long-term normoglycemia in full MHC mismatch recipient mice. PLoS ONE. 2012;7(12):e50265.
Kumar M, Nandi SK, Kaplan DL, Mandal BB. Localized immunomodulatory silk macrocapsules for islet-like spheroid formation and sustained insulin production. ACS Biomaterials Sci Eng. 2017;3(10):2443–56.
Hotaling NA, Tang L, Irvine DJ, Babensee JE. Biomaterial Strategies for Immunomodulation. Annu Rev Biomed Eng. 2015;17:317–49.
Shi Y, Zhao YZ, Jiang Z, Wang Z, Wang Q, Kou L, et al. Immune-Protective formulations and process strategies for improved survival and function of transplanted islets. Front Immunol. 2022;13:923241.
Zhang S, Yang H, Wang M, Mantovani D, Yang K, Witte F, et al. Immunomodulatory biomaterials against bacterial infections: Progress, challenges, and future perspectives. Innovation. 2023;4(6):100503.
Accolla RP, Simmons AM, Stabler CL. Integrating Additive Manufacturing techniques to improve cell-based implants for the treatment of type 1 diabetes. Adv Healthc Mater. 2022;11(13):e2200243.
Gross BC, Erkal JL, Lockwood SY, Chen C, Spence DM. Evaluation of 3D printing and its potential impact on biotechnology and the chemical sciences. ACS; 2014.
Bol RJ, Šavija B. Micromechanical models for FDM 3D-Printed polymers: a review. Polymers. 2023;15(23):4497.
Paul S. Finite element analysis in fused deposition modeling research: a literature review. Measurement. 2021;178:109320.
Monaldo E, Ricci M, Marfia S. Mechanical properties of 3D printed polylactic acid elements: experimental and numerical insights. Mech Mater. 2023;177:104551.
Anoop M, Senthil P. Microscale representative volume element based numerical analysis on mechanical properties of fused deposition modelling components. Materials Today: Proceedings. 2021;39:563 – 71.
McGuigan AP, Sefton MV. Vascularized organoid engineered by modular assembly enables blood perfusion. Proceedings of the National Academy of Sciences. 2006;103(31):11461-6.
Pedraza E, Coronel MM, Fraker CA, Ricordi C, Stabler CL. Preventing hypoxia-induced cell death in beta cells and islets via hydrolytically activated, oxygen-generating biomaterials. Proceedings of the National Academy of Sciences. 2012;109(11):4245-50.
Espona-Noguera A, Ciriza J, Cañibano-Hernández A, Orive G, Hernández RM, del Saenz L, et al. Review of advanced hydrogel-based cell encapsulation systems for insulin delivery in type 1 diabetes mellitus. Pharmaceutics. 2019;11(11):597.
Dimitrioglou N, Kanelli M, Papageorgiou E, Karatzas T, Hatziavramidis D. Paving the way for successful islet encapsulation. Drug Discovery Today. 2019;24(3):737–48.
Omer A, Duvivier-Kali V, Fernandes J, Tchipashvili V, Colton CK, Weir GC. Long-term normoglycemia in rats receiving transplants with encapsulated islets. Transplantation. 2005;79(1):52–8.
Song S, Roy S. Progress and challenges in macroencapsulation approaches for type 1 diabetes (T1D) treatment: cells, biomaterials, and devices. Biotechnol Bioeng. 2016;113(7):1381–402.
Zhi ZL, Kerby A, King AJF, Jones PM, Pickup JC. Nano-scale encapsulation enhances allograft survival and function of islets transplanted in a mouse model of diabetes. Diabetologia. 2012;55(4):1081–90.
Farina M, Chua CYX, Ballerini A, Thekkedath U, Alexander JF, Rhudy JR, et al. Transcutaneously refillable, 3D-printed biopolymeric encapsulation system for the transplantation of endocrine cells. Biomaterials. 2018;177:125–38.
Farina M, Ballerini A, Fraga DW, Nicolov E, Hogan M, Demarchi D et al. 3D printed vascularized device for Subcutaneous Transplantation of Human islets. Biotechnol J. 2017;12(9).
Lei D, Yang Y, Liu Z, Yang B, Gong W, Chen S, et al. 3D printing of biomimetic vasculature for tissue regeneration. Mater Horiz. 2019;6(6):1197–206.
Melchels FP, Domingos MA, Klein TJ, Malda J, Bartolo PJ, Hutmacher DW. Additive manufacturing of tissues and organs. Prog Polym Sci. 2012;37(8):1079–104.
Ernst AU, Wang LH, Ma M. Interconnected toroidal hydrogels for islet encapsulation. Adv Healthc Mater. 2019;8(12):1900423.
Liang J-P, Accolla RP, Jiang K, Li Y, Stabler CL. Controlled release of anti-inflammatory and proangiogenic factors from macroporous scaffolds. Tissue Eng Part A. 2021;27(19–20):1275–89.
Pedraza E, Brady A-C, Fraker CA, Molano RD, Sukert S, Berman DM, et al. Macroporous three-dimensional PDMS scaffolds for extrahepatic islet transplantation. Cell Transplant. 2013;22(7):1123–35.
Chiu Y-C, Cheng M-H, Engel H, Kao S-W, Larson JC, Gupta S, et al. The role of pore size on vascularization and tissue remodeling in PEG hydrogels. Biomaterials. 2011;32(26):6045–51.
Kuss MA, Wu S, Wang Y, Untrauer JB, Li W, Lim JY, et al. Prevascularization of 3D printed bone scaffolds by bioactive hydrogels and cell co-culture. J Biomedical Mater Res Part B: Appl Biomaterials. 2018;106(5):1788–98.
Liu X, Jakus AE, Kural M, Qian H, Engler A, Ghaedi M, et al. Vascularization of natural and synthetic bone scaffolds. Cell Transplant. 2018;27(8):1269–80.
Costa-Almeida R, Gomez-Lazaro M, Ramalho C, Granja PL, Soares R, Guerreiro SG. Fibroblast-endothelial partners for vascularization strategies in tissue engineering. Tissue Eng Part A. 2015;21(5–6):1055–65.
Newman AC, Nakatsu MN, Chou W, Gershon PD, Hughes CC. The requirement for fibroblasts in angiogenesis: fibroblast-derived matrix proteins are essential for endothelial cell lumen formation. Mol Biol Cell. 2011;22(20):3791–800.
Vlahos AE, Cober N, Sefton MV. Modular tissue engineering for the vascularization of subcutaneously transplanted pancreatic islets. Proceedings of the National Academy of Sciences. 2017;114(35):9337-42.
Farina M, Ballerini A, Fraga DW, Nicolov E, Hogan M, Demarchi D, et al. 3D printed vascularized device for subcutaneous transplantation of human islets. Biotechnol J. 2017;12(9):1700169.
Bertassoni LE, Cecconi M, Manoharan V, Nikkhah M, Hjortnaes J, Cristino AL, et al. Hydrogel bioprinted microchannel networks for vascularization of tissue engineering constructs. Lab Chip. 2014;14(13):2202–11.
Jia W, Gungor-Ozkerim PS, Zhang YS, Yue K, Zhu K, Liu W, et al. Direct 3D bioprinting of perfusable vascular constructs using a blend bioink. Biomaterials. 2016;106:58–68.
Gao Q, Liu Z, Lin Z, Qiu J, Liu Y, Liu A, et al. 3D bioprinting of vessel-like structures with multilevel fluidic channels. ACS Biomaterials Sci Eng. 2017;3(3):399–408.
Noor N, Shapira A, Edri R, Gal I, Wertheim L, Dvir T. 3D printing of personalized thick and perfusable cardiac patches and hearts. Adv Sci. 2019;6(11):1900344.
Hospodiuk M, Dey M, Ayan B, Sosnoski D, Moncal KK, Wu Y, et al. Sprouting angiogenesis in engineered pseudo islets. Biofabrication. 2018;10(3):035003.
Marchioli G, Luca AD, de Koning E, Engelse M, Van Blitterswijk CA, Karperien M, et al. Hybrid polycaprolactone/alginate scaffolds functionalized with VEGF to promote de novo vessel formation for the transplantation of islets of Langerhans. Adv Healthc Mater. 2016;5(13):1606–16.
Dionne KE, Colton CK, Lyarmush M. Effect of hypoxia on insulin secretion by isolated rat and canine islets of Langerhans. Diabetes. 1993;42(1):12–21.
de Groot M, Schuurs TA, Keizer PP, Fekken S, Leuvenink HG, Van Schilfgaarde R. Response of encapsulated rat pancreatic islets to hypoxia. Cell Transplant. 2003;12(8):867–75.
Thomas F, Wu J, Contreras JL, Smyth C, Bilbao G, He J, et al. A tripartite anoikis-like mechanism causes early isolated islet apoptosis. Surgery. 2001;130(2):333–8.
Barkai U, Rotem A, de Vos P. Survival of encapsulated islets: more than a membrane story. World J Transplantation. 2016;6(1):69.
Jiang K, Chaimov D, Patel SN, Liang JP, Wiggins SC, Samojlik MM, et al. 3-D physiomimetic extracellular matrix hydrogels provide a supportive microenvironment for rodent and human islet culture. Biomaterials. 2019;198:37–48.
Pati F, Jang J, Ha D, Won Kim S, Rhie J, Shim J, et al. Printing three-dimensional tissue analogues with decellularized extracellular matrix bioink. Nat Commun. 2014;5:3935.
Kim BS, Kwon YW, Kong J-S, Park GT, Gao G, Han W, et al. 3D cell printing of in vitro stabilized skin model and in vivo pre-vascularized skin patch using tissue-specific extracellular matrix bioink: a step towards advanced skin tissue engineering. Biomaterials. 2018;168:38–53.
Hu S, Martinez-Garcia FD, Moeun BN, Burgess JK, Harmsen MC, Hoesli C, et al. An immune regulatory 3D-printed alginate-pectin construct for immunoisolation of insulin producing β-cells. Mater Sci Engineering: C. 2021;123:112009.
Phelps EA, Templeman KL, Thulé PM, García AJ. Engineered VEGF-releasing PEG–MAL hydrogel for pancreatic islet vascularization. Drug Delivery Translational Res. 2015;5:125–36.
Kooptiwut S, Kaewin S, Semprasert N, Sujjitjoon J, Junking M, Suksri K, et al. Estradiol prevents high glucose-induced β-cell apoptosis by decreased BTG2 expression. Sci Rep. 2018;8(1):12256.
Dang TT, Thai AV, Cohen J, Slosberg JE, Siniakowicz K, Doloff JC, et al. Enhanced function of immuno-isolated islets in diabetes therapy by co-encapsulation with an anti-inflammatory drug. Biomaterials. 2013;34(23):5792–801.
Wang Y, He D, Ni C, Zhou H, Wu S, Xue Z, et al. Vitamin D induces autophagy of pancreatic β-cells and enhances insulin secretion. Mol Med Rep. 2016;14(3):2644–50.
Tarafder S, Koch A, Jun Y, Chou C, Awadallah MR, Lee CH. Micro-precise spatiotemporal delivery system embedded in 3D printing for complex tissue regeneration. Biofabrication. 2016;8(2):025003.
Liu YY, Yu HC, Liu Y, Liang G, Zhang T, Hu QX. Dual drug spatiotemporal release from functional gradient scaffolds prepared using 3 D bioprinting and electrospinning. Polym Eng Sci. 2016;56(2):170–7.
Freeman FE, Pitacco P, van Dommelen LH, Nulty J, Browe DC, Shin J-Y, et al. 3D bioprinting spatiotemporally defined patterns of growth factors to tightly control tissue regeneration. Sci Adv. 2020;6(33):eabb5093.
Wong MS, Hawthorne WJ, Manolios N. Gene therapy in diabetes. Self Nonself. 2010;1(3):165.
Ahmad Z, Rasouli M, Azman AZF, Omar AR. Evaluation of insulin expression and secretion in genetically engineered gut K and L-cells. BMC Biotechnol. 2012;12:1–9.
Tudurí E, Bruin JE, Kieffer TJ. Restoring insulin production for type 1 diabetes. J Diabetes. 2012;4(4):319–31.
Romer AI, Sussel L. Pancreatic islet cell development and regeneration. Current opinion in endocrinology, diabetes, and obesity. 2015;22(4):255.
Jaén ML, Vilà L, Elias I, Jimenez V, Rodó J, Maggioni L, et al. Long-term efficacy and safety of insulin and glucokinase gene therapy for diabetes: 8-year follow-up in dogs. Mol therapy-methods Clin Dev. 2017;6:1–7.
Li H, Li X, Lam KS, Tam S, Xiao W, Xu R. Adeno-associated virus-mediated pancreatic and duodenal homeobox gene-1 expression enhanced differentiation of hepatic oval stem cells to insulin-producing cells in diabetic rats. J Biomed Sci. 2008;15:487–97.
Schwitzgebel VM, Scheel DW, Conners JR, Kalamaras J, Lee JE, Anderson DJ, et al. Expression of neurogenin3 reveals an islet cell precursor population in the pancreas. Development. 2000;127(16):3533–42.
Abed A, Critchlow C, Flatt PR, McClenaghan NH, Kelly C. Directed differentiation of progenitor cells towards an islet-cell phenotype. Am J Stem Cells. 2012;1(3):196.
Zhao M, Amiel SA, Ajami S, Jiang J, Rela M, Heaton N, et al. Amelioration of streptozotocin-induced diabetes in mice with cells derived from human marrow stromal cells. PLoS ONE. 2008;3(7):e2666.
Handorf AM, Sollinger HW, Alam T. Genetic engineering of surrogate β cells for treatment of type 1 diabetes mellitus. J Diabetes Mellitus. 2015;5(04):295–312.
Grant MB, Adu-Agyeiwaah Y, Vieira CP, Asare-Bediako B, Hammer SS, Calzi SL, et al. Intravitreal administration of AAV2-SIRT1 reverses diabetic retinopathy (DR) in a murine model of type 2 diabetes (T2D). Investig Ophthalmol Vis Sci. 2022;63(7):2310.
Yoon J-W, Jun H-S. Recent advances in insulin gene therapy for type 1 diabetes. Trends Mol Med. 2002;8(2):62–8.
Hou W-R, Xie S-N, Wang H-J, Su Y-Y, Lu J-L, Li L-L, et al. Intramuscular delivery of a naked DNA plasmid encoding proinsulin and pancreatic regenerating III protein ameliorates type 1 diabetes mellitus. Pharmacol Res. 2011;63(4):320–7.
Joo WS, Jeong JH, Nam K, Blevins KS, Salama ME, Kim SW. Polymeric delivery of therapeutic RAE-1 plasmid to the pancreatic islets for the prevention of type 1 diabetes. J Controlled Release. 2012;162(3):606–11.
Dezashibi HM, Shabani A. A Mini-review of Current Treatment approaches and Gene Therapy as potential interventions for diabetes Mellitus types 1. Adv Biomed Res. 2023;12:219.
Vantyghem M-C, de Koning EJ, Pattou F, Rickels MR. Advances in β-cell replacement therapy for the treatment of type 1 diabetes. Lancet. 2019;394(10205):1274–85.
Hudson A, Bradbury L, Johnson R, Fuggle S, Shaw J, Casey J, et al. The UK pancreas allocation scheme for whole organ and islet transplantation. Am J Transplant. 2015;15(9):2443–55.
Cornateanu SM, O’Neill S, Dholakia S, Counter CJ, Sherif AE, Casey JJ, et al. Pancreas utilization rates in the UK–an 11-year analysis. Transpl Int. 2021;34(7):1306–18.
Nordheim E, Lindahl JP, Carlsen RK, Åsberg A, Birkeland KI, Horneland R, et al. Patient selection for islet or solid organ pancreas transplantation: experiences from a multidisciplinary outpatient-clinic approach. Endocr Connections. 2021;10(2):230–9.
Arifin DR, Bulte JW. In vivo imaging of pancreatic islet grafts in diabetes treatment. Front Endocrinol. 2021;12:640117.
Murakami T, Fujimoto H, Inagaki N. Non-invasive beta-cell imaging: visualization, quantification, and beyond. Front Endocrinol. 2021;12:714348.
Piemonti L, Everly MJ, Maffi P, Scavini M, Poli F, Nano R, et al. Alloantibody and autoantibody monitoring predicts islet transplantation outcome in human type 1 diabetes. Diabetes. 2013;62(5):1656–64.
Anteby R, Lucander A, Bachul PJ, Pyda J, Grybowski D, Basto L, et al. Evaluating the prognostic value of islet autoantibody monitoring in islet transplant recipients with long-standing type 1 diabetes mellitus. J Clin Med. 2021;10(12):2708.
Buron F, Reffet S, Badet L, Morelon E, Thaunat O. Immunological monitoring in beta cell replacement: towards a pathophysiology-guided implementation of biomarkers. Curr Diab Rep. 2021;21:1–11.
Cantarelli E, Piemonti L. Alternative transplantation sites for pancreatic islet grafts. Curr Diab Rep. 2011;11:364–74.
Tremmel DM, Odorico JS. Rebuilding a better home for transplanted islets. Organogenesis. 2018;14(4):163–8.
Citro A, Moser PT, Dugnani E, Rajab TK, Ren X, Evangelista-Leite D, et al. Biofabrication of a vascularized islet organ for type 1 diabetes. Biomaterials. 2019;199:40–51.
Basta G, Montanucci P, Calafiore R. Microencapsulation of cells and molecular therapy of type 1 diabetes mellitus: the actual state and future perspectives between promise and progress. J Diabetes Invest. 2021;12(3):301–9.
Samojlik MM, Stabler CL. Designing biomaterials for the modulation of allogeneic and autoimmune responses to cellular implants in type 1 diabetes. Acta Biomater. 2021;133:87–101.
Carlsson P-O, Schwarcz E, Korsgren O, Le Blanc K. Preserved β-cell function in type 1 diabetes by mesenchymal stromal cells. Diabetes. 2015;64(2):587–92.
Madani S, Setudeh A, Aghayan HR, Alavi-Moghadam S, Rouhifard M, Rezaei N, et al. Placenta derived mesenchymal stem cells transplantation in type 1 diabetes: preliminary report of phase 1 clinical trial. J Diabetes Metabolic Disorders. 2021;20:1179–89.
Pagliuca FW, Millman JR, Gürtler M, Segel M, Van Dervort A, Ryu JH, et al. Generation of functional human pancreatic β cells in vitro. Cell. 2014;159(2):428–39.
Russ HA, Parent AV, Ringler JJ, Hennings TG, Nair GG, Shveygert M, et al. Controlled induction of human pancreatic progenitors produces functional beta-like cells in vitro. EMBO J. 2015;34(13):1759–72.
Sambathkumar R, Migliorini A, Nostro MC. Pluripotent stem cell-derived pancreatic progenitors and β-like cells for type 1 diabetes treatment. Physiology. 2018;33(6):394–402.
Sordi V, Monaco L, Piemonti L. Cell therapy for type 1 diabetes: from islet transplantation to stem cells. Hormone Res Paediatrics. 2022;96(6):658–69.
Henry RR, Pettus J, Wilensky J, SHAPIRO AJ, Senior PA, Roep B et al. Initial clinical evaluation of VC-01TM combination product—a stem cell–derived islet replacement for type 1 diabetes (T1D). Diabetes. 2018;67(Supplement_1).
Shapiro A, Thompson D, Donner TW, Bellin MD, Hsueh W, Pettus JH et al. Insulin expression and glucose-responsive circulating C-peptide in type 1 diabetes patients implanted subcutaneously with pluripotent stem cell-derived pancreatic endoderm cells in a macro-device. David and Donner, Thomas W and Bellin, Melena D and Hsueh, Willa and Pettus, Jeremy H and Wilensky, Jon S and Daniels, Mark and Wang, Richard M and Kroon, Evert J and Brandon, Eugene Paul and D’Amour, Kevin A and Foyt, Howard, Insulin Expression and Glucose-Responsive Circulating C-Peptide in Type. 2019;1.
Keymeulen B, Jacobs-Tulleneers-Thevissen D, Kroon EJ, Jaiman MS, Daniels M, Wang R et al. 196-LB: stem cell–derived islet replacement therapy (VC-02) demonstrates production of C-peptide in patients with type 1 diabetes (T1D) and hypoglycemia unawareness. Diabetes. 2021;70(Supplement_1).
Piemonti L. Felix dies natalis, insulin… ceterum autem censeo beta is better. Acta Diabetol. 2021;58(10):1287–306.
Sordi V, Pellegrini S, Piemonti L. Immunological issues after stem cell-based β cell replacement. Curr Diab Rep. 2017;17:1–8.
Coe TM, Markmann JF, Rickert CG. Current status of porcine islet xenotransplantation. Curr Opin Organ Transpl. 2020;25(5):449–56.
Edgar L, Pu T, Porter B, Aziz J, La Pointe C, Asthana A, et al. Regenerative medicine, organ bioengineering and transplantation. J Br Surg. 2020;107(7):793–800.
Mathur A, Taurin S, Alshammary S. The safety and efficacy of mesenchymal stem cells in the treatment of type 2 Diabetes- A literature review. Diabetes Metab Syndr Obes. 2023;16:769–77.
Hogrebe NJ, Ishahak M, Millman JR. Developments in stem cell-derived islet replacement therapy for treating type 1 diabetes. Cell Stem Cell. 2023;30(5):530–48.
Paraskevas S, Maysinger D, Wang R, Duguid WP, Rosenberg L. Cell loss in isolated human islets occurs by apoptosis. Pancreas. 2000;20(3):270–6.
Kelly OG, Chan MY, Martinson LA, Kadoya K, Ostertag TM, Ross KG, et al. Cell-surface markers for the isolation of pancreatic cell types derived from human embryonic stem cells. Nat Biotechnol. 2011;29(8):750–6.
Rezania A, Bruin JE, Riedel MJ, Mojibian M, Asadi A, Xu J, et al. Maturation of human embryonic stem cell–derived pancreatic progenitors into functional islets capable of treating pre-existing diabetes in mice. Diabetes. 2012;61(8):2016–29.
Kroon E, Martinson LA, Kadoya K, Bang AG, Kelly OG, Eliazer S, et al. Pancreatic endoderm derived from human embryonic stem cells generates glucose-responsive insulin-secreting cells in vivo. Nat Biotechnol. 2008;26(4):443–52.
Agulnick AD, Ambruzs DM, Moorman MA, Bhoumik A, Cesario RM, Payne JK, et al. Insulin-producing endocrine cells differentiated in vitro from human embryonic stem cells function in macroencapsulation devices in vivo. Stem Cells Translational Med. 2015;4(10):1214–22.
Ramzy A, Thompson DM, Ward-Hartstonge KA, Ivison S, Cook L, Garcia RV, et al. Implanted pluripotent stem-cell-derived pancreatic endoderm cells secrete glucose-responsive C-peptide in patients with type 1 diabetes. Cell Stem Cell. 2021;28(12):2047–61. e5.
Dolgin E, Diabetes. Encapsulating the problem. Nature. 2016;540(7632):S60–2.
Rezania A, Bruin JE, Arora P, Rubin A, Batushansky I, Asadi A, et al. Reversal of diabetes with insulin-producing cells derived in vitro from human pluripotent stem cells. Nat Biotechnol. 2014;32(11):1121–33.
Hogrebe NJ, Augsornworawat P, Maxwell KG, Velazco-Cruz L, Millman JR. Targeting the cytoskeleton to direct pancreatic differentiation of human pluripotent stem cells. Nat Biotechnol. 2020;38(4):460–70.
Nair GG, Liu JS, Russ HA, Tran S, Saxton MS, Chen R, et al. Recapitulating endocrine cell clustering in culture promotes maturation of human stem-cell-derived β cells. Nat Cell Biol. 2019;21(2):263–74.
Shapiro AJ, Thompson D, Donner TW, Bellin MD, Hsueh W, Pettus J et al. Insulin expression and C-peptide in type 1 diabetes subjects implanted with stem cell-derived pancreatic endoderm cells in an encapsulation device. Cell Rep Med. 2021;2(12).
Witkowski P, Anteby R, Olaitan OK, Forbes RC, Niederhaus S, Ricordi C, et al. Pancreatic islets Quality and Potency cannot be verified as required for drugs: reflection on the FDA Review of a biological license application for human islets. Transplantation. 2021;105(12):e409–10.