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cGMP Advanced Cell and Biologic Product Manufacturing Facility

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  • Qadir MMF, Álvarez-Cubela S, Klein D, Lanzoni G, García-Santana C, Montalvo A, Pláceres-Uray F, Mazza EMC, Ricordi C, Inverardi LA, Pastori RL, Domínguez-Bendala J. P2RY1/ALK3-Expressing Cells within the Adult Human Exocrine Pancreas Are BMP-7 Expandable and Exhibit Progenitor-like Characteristics. Cell Rep. 2018 Feb 27;22(9):2408-2420.

  • Buchwald P, Tamayo-Garcia A, Manzoli V, Tomei AA, Stabler CL (2018) Glucose-stimulated insulin release: Parallel perifusion studies of free and hydrogel encapsulated human pancreatic islets. Biotechnol Bioeng. 2018 Jan;115(1):232-245.

  • Foster ED, Bridges ND, Feurer ID, Eggerman TL, Hunsicker LG, Alejandro R; Clinical Islet Transplantation Consortium. Improved Health-Related Quality of Life in a Phase 3 Islet Transplantation Trial in Type 1 Diabetes Complicated by Severe Hypoglycemia. Diabetes Care. 2018 May;41(5):1001-1008.

  • Baidal DA, Ricordi C, Berman DM, Alvarez A, Padilla N, Ciancio G, Linetsky E, Pileggi A, Alejandro R. Bioengineering of an Intraabdominal Endocrine Pancreas. N Engl J Med. 2017 May 11;376(19):1887-1889.

  • Garcia-Contreras M, Tamayo-Garcia A, Pappan KL, Michelotti GA, Stabler CL, Ricordi C, Buchwald P. (2017) Metabolomics Study of the Effects of Inflammation, Hypoxia, and High Glucose on Isolated Human Pancreatic Islets. J Proteome Res. 2017 Jun 2;16(6):2294-2306.

  • Ricordi C, Goldstein JS, Balamurugan AN, Szot GL, Kin T, Liu C, Czarniecki CW, Barbaro B, Bridges ND, Cano J, Clarke WR, Eggerman TL, Hunsicker LG, Kaufman DB, Khan A, Lafontant DE, Linetsky E, Luo X, Markmann JF, Naji A, Korsgren O, Oberholzer J, Turgeon NA, Brandhorst D, Chen X, Friberg AS, Lei J, Wang LJ, Wilhelm JJ, Willits J, Zhang X, Hering BJ, Posselt AM, Stock PG, Shapiro AM, Chen X. Diabetes. 2016 Nov;65(11):3418-3428.

  • Hering BJ, Clarke WR, Bridges ND, Eggerman TL, Alejandro R, Bellin MD, Chaloner K, Czarniecki CW, Goldstein JS, Hunsicker LG, Kaufman DB, Korsgren O, Larsen CP, Luo X, Markmann JF, Naji A, Oberholzer J, Posselt AM, Rickels MR, Ricordi C, Robien MA, Senior PA, Shapiro AM, Stock PG, Turgeon NA; Clinical Islet Transplantation Consortium Diabetes Care. 2016 Jul;39(7):1230-40.

  • Buchwald P, Bernal A, Echeverri F, Tamayo-Garcia A, Linetsky E, Ricordi C. Fully Automated Islet Cell Counter (ICC) for the Assessment of Islet Mass, Purity, and Size Distribution by Digital Image Analysis. Cell Transplant. 2016 Oct;25(10):1747-1761.

  • Zoso, A., Serafini, P., Lanzoni, G., Peixoto, E., Messinger, S., Mantero, A., ... Inverardi, L. G-CSF and Exenatide Might Be Associated with Increased Long-Term Survival of Allogeneic Pancreatic Islet Grafts. 2016 PLoS One, 11(6), e0157245.

  • Wang LJ, Kin T, O'Gorman D, Shapiro AMJ, Naziruddin B, Takita M, Levy MF, Posselt AM, Szot GL, Savari O, Barbaro B, McGarrigle J, Yeh CC, Oberholzer J, Lei J, Chen T, Lian M, Markmann JF, Alvarez A, Linetsky E, Ricordi C, Balamurugan AN, Loganathan G, Wilhelm JJ, Hering BJ, Bottino R, Trucco M, Liu C, Min Z, Li Y, Naji A, Fernandez LA, Ziemelis M, Danobeitia JS, Millis JM, Witkowski P. A Multicenter Study: North American Islet Donor Score in Donor Pancreas Selection for Human Islet Isolation for Transplantation. Cell Transplant. 2016;25(8):1515-1523.

  • Dagmar Klein,1 Silvia Álvarez-Cubela, Giacomo Lanzoni, Nancy Vargas, Kamalaveni R. Prabakar, Maria Boulina,1 Camillo Ricordi, Luca Inverardi, Ricardo L. Pastori, and Juan Domínguez-Bendala1, BMP-7 Induces Adult Human Pancreatic Exocrine-to-Endocrine Conversion. Diabetes. 2015 Dec;64(12):4123-34.

  • Linetsky E, Arslan MS, Alejandro R & Ricordi C. Islet Autotransplantation: Past, Present and Future. Chapter I: chronic pancreatitis: pathogenesis, indications and treatment. Diabetes Manag. 2015, 5(1) 37-50.

  • Linetsky E, Arslan MS, Alejandro R & Ricordi C. Islet Autotransplantation: Past, Present and Future. Chapter II: the role of islet autotransplantation for the treatment of chronic pancreatitis. Diabetes Manag. 2015, 5(2) 103-118.

  • Molina J, Berggren PO, Caicedo A. Control of Insulin Secretion by Cholinergic Signaling in the Human Pancreatic Islet. Diabetes, 2014 Aug; 63(8): 2274-2726.

  • Minonzio G, Linetsky E. The Use of Fetal Bovine Serum in Cellular Products for Clinical Applications: Commentary. CellR4 2014, 2 (6):e1307.

  • Linetsky E, Inverardi L, Ricordi C. Cell Replacement Therapy in Type I Diabetes. In Escher AP, Li A, Eds. Type I Diabetes. February 27, 2013. ISBN 978-953-51-1017-0.

  • Klein D, Misawa R, Bravo-Egana V, Vargas N,  Piroso J, Ichii H,  Umland O,  Zhijie J,  Nicholas Tsinoremas N,  Ricordi C,  Inverardi L,  Domínguez-Bendala J,  and Pastori RL. MicroRNA Expression in Plpha and Teba Cells in Human Pancreatic Islets. PloS One. 2013 8(1): e55064. Published online 2013 Jan 29. Doi:  10.1371/journal.pone.0055064

  • Fraker CA1, Cechin S, Álvarez-Cubela S, Echeverri F, Bernal A, Poo R, Ricordi C, Inverardi L, Domínguez-Bendala J. A physiological pattern of oxygenation using perfluorocarbon-based culture devices maximizes pancreatic islet viability and enhances β-cell function. Cell Transplant. 2013;22(9):1723-33.

  • Rodriguez-Diaz R, Speier S, Molano RD, Formoso A, Gans I, Abdulreda MH, Cabrera O, Molina J, Fachado A, Ricordi C, Leibiger I, Pileggi A, Berggren PO, Caicedo A. Noninvasive in vivo model demonstrating the effects of autonomic innervation on pancreatic islet function. Proc Natl Acad Sci U S A. 2012 Dec 26;109(52):21456-61.

  • Cechin SR, Pérez-Álvarez I, Fenjves E, Molano RD, Pileggi A, Berggren PO, Ricordi C, Pastori RL. Anti-Inflammatory properties of exenatide in human pancreatic islets. Cell Transplant.2012 21(4):633-48.

  • Khan A, Jindal RM, Shriver C, Guy SR, Vertrees AE, Wang X, Xu X, Szust J, Ricordi C. (2012) Remote processing of pancreas can restore normal glucose homeostasis in autologous islet transplantation after traumatic whipple pancreatectomy: technical considerations. Cell Transplant. 2012;21(6):1261-7.

  • Rodriguez-Diaz R, Abdulreda MH, Formoso AL, Gans I, Ricordi C, Berggren PO, Caicedo A. Innervation patterns of autonomic axons in the human endocrine pancreas. Cell Metab. 2011 Jul 6;14(1):45-54.

  • Peixoto EM, Froud T, Gomes LS, Zavala LM, Corrales A, Herrada E, Ricordi C, Alejandro R. Effect of exenatide on gastric emptying and graft survival in islet allograft recipients. Transplant Proc. 2011 Nov;43(9):3231-4.

  • Jacques-Silva MC, Correa-Medina M, Cabrera O, Rodriguez-Diaz R, Makeeva N, Fachado A, Diez J, Berman DM, Kenyon NS, Ricordi C, Pileggi A, Molano RD, Berggren PO, Caicedo A. ATP-gated P2X3 receptors constitute a positive autocrine signal for insulin release in the human pancreatic beta cell. Proc Natl Acad Sci U S A. 2010 Apr 6;107(14):6465-70.

  • Hirsch D, Odorico J, Radke N, Hanson M, Danobeitia JS, Hullett D, Alejandro R, Ricordi C, Fernandez LA. Correction of insulin sensitivity and glucose disposal after pancreatic islet transplantation: preliminary results. Diabetes Obes Metab. 2010 Nov;12(11):994-1003.

  • Leitão CB, Bernetti K, Tharavanij T, Cure P, Lauriola V, Berggren PO, Ricordi C, Alejandro R. (2010) Lipotoxicity and decreased islet graft survival. Diabetes Care. Mar;33(3):658-60.

  • Kissler HJ, Niland JC, Olack B, Ricordi C, Hering BJ, Naji A, Kandeel F, Oberholzer J, Fernandez L, Contreras J, Stiller T, Sowinski J, Kaufman DB. Validation of methodologies for quantifying isolated human isles: An Islet Cell Resource study. Clin Transplant. 2010 Mar-Apr;24(2):236-42.

  • Buchwald P, Wang X, Khan A, Bernal A, Fraker C, Inverardi L, Ricordi C Quantitative assessment of islet cell products: estimating the accuracy of the existing protocol and accounting for islet size distribution. Cell Transplant. 2009 18(10):1223-35.

  • Faradji RN, Froud T, Messinger S, Monroy K, Pileggi A, Mineo D, Tharavanij T, Mendez AJ, Ricordi C, Alejandro R. Long-term metabolic and hormonal effects of exenatide on islet transplant recipients with allograft dysfunction. Cell Transplant. 2009 18(10):1247-59.

  • Mineo D, Sageshima J, Burke GW, Ricordi C. (2009) Minimization and withdrawal of steroids in pancreas and islet transplantation. Transpl Int. 2009 Jan;22(1):20-37.

  • Baidal DA, Faradji RN, Messinger S, Froud T, Monroy K, Ricordi C, Alejandro R. (2009) Early metabolic markers of islet allograft dysfunction. Transplantation. 2009 Mar 15;87(5):689-97.

  • Leitão CB, Cure P, Messinger S, Pileggi A, Lenz O, Froud T, Faradji RN, Selvaggi G, Kupin W, Ricordi C, Alejandro R. Stable renal function after islet transplantation: importance of patient selection and aggressive clinical management. Transplantation. 2009 Mar 15;87(5):681-8.

  • Linetsky E, Khan A, Ricordi C. Pancreastic Islet cells. In Areman EM, Loper, K, eds. Cellular Therapy: Principles, Methods, and Regulations. Section VII, Production: Complex and Extensive Processing. Bethesda, MD: AABB, 2009.

  • Linetsky E. Pancreatic Islet Characterization. In Areman EM, Loper, K, eds. Cellular Therapy: Principles, Methods, and Regulations. Section VII, Production: Complex and Extensive Processing. Bethesda, MD: AABB, 2009.

  • Linetsky E, Ricordi C. Regulatory Challenges in Manufacturing of Pancreatic Islets. Transplant Proc.  Mar;40(2):424-6. Transplant Proc. 2008 Jan-Feb;41(1):354-5.

  • Froud T, Baidal DA, Faradji R, Cure P, Mineo D, Selvaggi G, Kenyon NS, Ricordi C, Alejandro R. Islet transplantation with alemtuzumab induction and calcineurin-free maintenance immunosuppression results in improved short- and long-term outcomes. Transplantation. 2008 Dec 27;86(12):1695-701.

  • Faradji RN, Tharavanij T, Messinger S, Froud T, Pileggi A, Monroy K, Mineo D, Baidal DA, Cure P, Ponte G, Mendez AJ, Selvaggi G, Ricordi C, Alejandro R. Long-term insulin independence and improvement in insulin secretion after supplemental islet infusion under exenatide and etanercept. Transplantation. 2008 Dec 27;86(12):1658-65.

  • Tharavanij T, Betancourt A, Messinger S, Cure P, Leitao CB, Baidal DA, Froud T, Ricordi C, Alejandro R. Improved long-term health-related quality of life after islet transplantation. Transplantation. 2008 Nov 15;86(9):1161-7.

  • Martin-Pagola A, Sisino G, Allende G, Dominguez-Bendala J, Gianani R, Reijonen H, Nepom GT, Ricordi C, Ruiz P, Sageshima J, Ciancio G, Burke GW, Pugliese A. Insulin protein and proliferation in ductal cells in the transplanted pancreas of patients with type 1 diabetes and recurrence of autoimmunity. Diabetologia. 2008 Oct;51(10):1803-13.

  • Mita A, Ricordi C, Miki A, Barker S, Haertter R, Hashikura Y, Miyagawa S, Burke GW 3rd, Inverardi L, Ichii H. Anti-proinflammatory effects of sirolimus on human islet preparations. Transplantation. 2008 Jul 15;86(1):46-53.

  • Fenjves ES, Ochoa MS, Cechin S, Gay-Rabinstein C, Pérez-Alvarez I, Ichii H, Mendez A, Ricordi C, Curran MA. Protection of human pancreatic islets using a lentiviral vector expressing two genes: cFLIP and GFP. Cell Transplant. 2008;17(7):793-802.

  • Froud T, Faradji RN, Pileggi A, Messinger S, Baidal DA, Ponte GM, Cure PE, Monroy K, Mendez A, Selvaggi G, Ricordi C, Alejandro R. The use of exenatide in islet transplant recipients with chronic allograft dysfunction: safety, efficacy, and metabolic effects. Transplantation. 2008 Jul 15;86(1):36-45.

  • Mineo D, Ricordi C, Xu X, Pileggi A, Garcia-Morales R, Khan A, Baidal DA, Han D, Monroy K, Miller J, Pugliese A, Froud T, Inverardi L, Kenyon NS, Alejandro R. Combined islet and hematopoietic stem cell allotransplantation: a clinical pilot trial to induce chimerism and graft tolerance. Am J Transplant. 2008 Jun;8(6):1262-74.

  • Leitão CB, Tharavanij T, Cure P, Pileggi A, Baidal DA, Ricordi C, Alejandro R. Restoration of hypoglycemia awareness after islet transplantation. Diabetes Care. 2008 Nov;31(11):2113-5.

  • Cure P, Pileggi A, Froud T, Messinger S, Faradji RN, Baidal DA, Cardani R, Curry A, Poggioli R, Pugliese A, Betancourt A, Esquenazi V, Ciancio G, Selvaggi G, Burke GW 3rd, Ricordi C, Alejandro R. Improved metabolic control and quality of life in seven patients with type 1 diabetes following islet after kidney transplantation. Transplantation. 2008 Mar 27;85(6):801-12.

  • Antonioli B, Fermo I, Cainarca S, Marzorati S, Nano R, Baldissera M, Bachi A, Paroni R, Ricordi C, Bertuzzi F. Characterization of collagenase blend enzymes for human islet transplantation. Transplantation. 2007 Dec 27;84(12):1568-75.

  • Cabrera O, Jacques-Silva MC, Berman DM, Fachado A, Echeverri F, Poo R, Khan A, Kenyon NS, Ricordi C, Berggren PO, Caicedo A. Automated, High-Throughput Assays for Evaluation of Human Pancreatic Islet Function. Cell Transplant. 2007 Nov;16(10):1039-1048.

  • Fraker C, Timmins MR, Guarino RD, Haaland PD, Ichii H, Molano D, Pileggi A, Poggioli R, Presnell SC, Inverardi L, Zehtab M, Ricordi C. The use of the BD oxygen biosensor system to assess isolated human islets of langerhans: oxygen consumption as a potential measure of islet potency. Cell Transplant. 2006 15(8-9):745-58.

  • Cabrera O, Berman DM, Kenyon NS, Ricordi C,  Berggren PO, and Caicedo A. The unique cytoarchitecture of human pancreatic islets has implications for islet cells function. Proc Natl Acad Sci USA, 2006 Feb 14; 103(7): 2334–233.

  • Barbé-Tuana FM, Klein D, Ichii H, Berman DM, Coffey L, Kenyon NS, Ricordi C, Pasotri R. CD40-CD40 Ligand Interaction Activates Proinflammatory Pathways in Pancreatic Islets. Diabetes. 2006 Sep;55(9):2437-45.

  • Fraker C, Montelongo J, Szust J, Khan A, Ricordi C. The use of multiparametric monitoring during islet cell isolation and culture: a potential tool for in-process corrections of critical physiological factors. Cell Transplant. 2004;13(5):497-502.

  • Han D, Xu X, Baidal D, Leith J, Ricordi C, Alejandro R, Kenyon NS. Assessment of cytotoxic lymphocyte gene expression in the peripheral blood of human islet allograft recipients: elevation precedes clinical evidence of rejection. Diabetes. 2004 Sep;53(9):2281-90.

  • Ricordi C, Fraker C, Szust J, Al-Abdullah I, Poggioli R, Kirlew T, Khan A, Alejandro R. Improved human islet isolation outcome from marginal donors following addition of oxygenated perfluorocarbon to the cold-storage solution. Transplantation. 2003 May 15;75(9):1524-7.

  • Inverardi L, Linetsky E, Molano RD, Pileggi A, Serafini A, Paganelli G, Ricordi C.  153Sm Lexidronam: a novel targeted radioisotopic strategy for induction of stable multilineage chimerism.  Cell Transplant 2001 10(6):522.

  • Inverardi L, Linetsky E, Molano RD, Pileggi A, Serafini A, Paganelli G, Ricordi C.  Long term skin allograft survival following donor specific chimerism induction with a novel targeted bone marrow radioablation and co-stimulatory blockade.  Am J Transplant  2002 2(S3):255.

  • Inverardi L, Linetsky E, Molano RD, Pileggi A, Serafini A, Paganelli G, Ricordi C.  Long term skin allograft survival following donor specific chimerism induction with a novel targeted bone marrow radioablation and co-stimulatory blockade.  CellTransplant 2001 10(6):524.

  • Seufert J, Kieffer TJ, Leech CA, Holz GG, Moritz W, Ricordi C, Habener JF. Leptin suppression of insulin secretion and gene expression in human pancreatic islets: implications for the development of adipogenic diabetes mellitus. J Clin Endocrinol Metab. 1999 Feb;84(2):670-6.

  • Linetsky E, Inverardi L, Kenyon NS, Alejandro R, Ricordi C. Endotoxin contamination of reagents used during isolation and purification of human pancreatic islets. Transplant Proc. 1998 Mar;30(2):345-6

  • Linetsky E, Bottino R, Lehmann R, Alejandro R, Inverardi L, Ricordi C. (1997) Improved human islet isolation using a new enzyme blend, Liberase™. Diabetes. 1997 Jul;46(7):1120-3.
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cGMP Advanced Cell and Biologic Product Manufacturing Facility, 1450 Northwest 10th Avenue, Miami, FL, 33136, United States(305) 243-3517X.XU@MED.MIAMI.EDU

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