Process parameter development for the scaled generation of stem cell-derived pancreatic endocrine cells.
TLDR
In this article, the potential of both stem cell-derived pancreatic progenitors and more matured insulin-producing cells to treat diabetes is discussed, and the need for rigorous bioprocess parameter optimization and identifying some critical process parameters and strategies that may influence the critical quality attributes of the cells with the goal of facilitating scalable manufacturing of human pluripotent stem cell derived pancreatic endocrine cells.Abstract:
Diabetes is a debilitating disease characterized by high blood glucose levels. The global prevalence of this disease has been projected to reach 700 million adults by the year 2045. Type 1 diabetes represents about 10% of the reported cases of diabetes. Although islet transplantation can be a highly effective method to treat type 1 diabetes, its widespread application is limited by the paucity of cadaveric donor islets. The use of pluripotent stem cells as an unlimited cell source to generate insulin-producing cells for implant is a promising alternative for treating diabetes. However, to be clinically relevant, it is necessary to manufacture these stem cell-derived cells at sufficient scales. Significant advances have been made in differentiation protocols used to generate stem cell-derived cells capable of reversing diabetes in animal models and for testing in clinical trials. We discuss the potential of both stem cell-derived pancreatic progenitors and more matured insulin-producing cells to treat diabetes. We discuss the need for rigorous bioprocess parameter optimization and identify some critical process parameters and strategies that may influence the critical quality attributes of the cells with the goal of facilitating scalable manufacturing of human pluripotent stem cell-derived pancreatic endocrine cells.read more
Citations
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Implanted pluripotent stem-cell-derived pancreatic endoderm cells secrete glucose-responsive C-peptide in patients with type 1 diabetes.
Adam Ramzy,David M. Thompson,Kirsten A. Ward-Hartstonge,Sabine Ivison,Laura Cook,Rosa Garcia,Jackson Loyal,Peter T. W. Kim,Garth L. Warnock,Megan K. Levings,Timothy J. Kieffer +10 more
TL;DR: Shapiro et al. as discussed by the authors evaluated the safety and efficacy of pancreatic endoderm cells (PECs) implanted in non-immunoprotective macroencapsulation devices for the treatment of type 1 diabetes.
References
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Induction of Pluripotent Stem Cells from Adult Human Fibroblasts by Defined Factors
Kazutoshi Takahashi,Koji Tanabe,Mari Ohnuki,Megumi Narita,Tomoko Ichisaka,Kiichiro Tomoda,Shinya Yamanaka +6 more
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Islet Transplantation in Seven Patients with Type 1 Diabetes Mellitus Using a Glucocorticoid-Free Immunosuppressive Regimen
A. M. J. Shapiro,Jonathan R. T. Lakey,Edmond A. Ryan,Gregory S. Korbutt,Ellen L. Toth,Garth L. Warnock,Norman M. Kneteman,Ray V. Rajotte +7 more
TL;DR: The observations in patients with type 1 diabetes indicate that islet transplantation can result in insulin independence with excellent metabolic control when glucocorticoid-free immunosuppression is combined with the infusion of an adequate islet mass.
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A ROCK inhibitor permits survival of dissociated human embryonic stem cells
Kiichi Watanabe,Morio Ueno,Daisuke Kamiya,Ayaka Nishiyama,Michiru Matsumura,Takafumi Wataya,Jun Takahashi,Satomi Nishikawa,Shin-Ichi Nishikawa,Keiko Muguruma,Yoshiki Sasai +10 more
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Production of pancreatic hormone–expressing endocrine cells from human embryonic stem cells
Kevin A. D'Amour,Anne G. Bang,Susan Eliazer,Olivia Kelly,Alan D. Agulnick,Nora G Smart,Mark A. Moorman,Evert Kroon,Melissa K Carpenter,Emmanuel E. Baetge +9 more
TL;DR: A differentiation process that converts human embryonic stem cells to endocrine cells capable of synthesizing the pancreatic hormones insulin, glucagon, somatostatin, pancreatic polypeptide and ghrelin is developed.