Insulin expression and C-peptide in type 1 diabetes subjects implanted with stem cell-derived pancreatic endoderm cells in an encapsulation device

These preliminary data from an ongoing first-in-human phase 1/2, open-label study provide proof-of-concept that pluripotent stem cell-derived pancreatic endoderm cells (PEC-01) engrafted in type 1 diabetes patients become islet cells releasing insulin in a physiologically regulated fashion. In this...

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Veröffentlicht in:Cell reports. Medicine 2021-12, Vol.2 (12), p.100466-100466, Article 100466
Hauptverfasser: Shapiro, A.M. James, Thompson, David, Donner, Thomas W., Bellin, Melena D., Hsueh, Willa, Pettus, Jeremy, Wilensky, Jon, Daniels, Mark, Wang, Richard M., Brandon, Eugene P., Jaiman, Manasi S., Kroon, Evert J., D’Amour, Kevin A., Foyt, Howard L.
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container_end_page 100466
container_issue 12
container_start_page 100466
container_title Cell reports. Medicine
container_volume 2
creator Shapiro, A.M. James
Thompson, David
Donner, Thomas W.
Bellin, Melena D.
Hsueh, Willa
Pettus, Jeremy
Wilensky, Jon
Daniels, Mark
Wang, Richard M.
Brandon, Eugene P.
Jaiman, Manasi S.
Kroon, Evert J.
D’Amour, Kevin A.
Foyt, Howard L.
description These preliminary data from an ongoing first-in-human phase 1/2, open-label study provide proof-of-concept that pluripotent stem cell-derived pancreatic endoderm cells (PEC-01) engrafted in type 1 diabetes patients become islet cells releasing insulin in a physiologically regulated fashion. In this study of 17 subjects aged 22-57 with type 1 diabetes, PEC-01 cells were implanted subcutaneously in VC-02 macroencapsulation devices, allowing for direct vascularization of the cells. Engraftment and insulin expression were observed in 63% of VC-02 units explanted from subjects at 3–12 months post-implant. Six of 17 subjects (35.3%) demonstrated positive C-peptide as early as 6 months post-implant. Most reported adverse events were related to surgical implant or explant procedures (27.9%) or to side-effects of immunosuppression (33.7%). Initial data suggest that pluripotent stem cells, which can be propagated to the desired biomass and differentiated into pancreatic islet-like tissue, may offer a scalable, renewable alternative to pancreatic islet transplants. [Display omitted] •Findings are shared for the first 17 participants in a phase 1/2 trial of VC-02•This investigational device was implanted into type 1 diabetes patients•VC-02 contains pluripotent stem cell-derived pancreatic endoderm cells•C-peptide levels and insulin expression correlate with engraftment in 63% of subjects Shapiro et al. report preliminary proof-of-concept that in 17 people with type 1 diabetes, pancreatic endoderm cells in an investigational subcutaneous device (VC-02) achieved engraftment and insulin expression in 63% of units at 3–12 months post-implant. Pluripotent stem cells may be a scalable, renewable alternative to pancreatic islet transplants.
doi_str_mv 10.1016/j.xcrm.2021.100466
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James ; Thompson, David ; Donner, Thomas W. ; Bellin, Melena D. ; Hsueh, Willa ; Pettus, Jeremy ; Wilensky, Jon ; Daniels, Mark ; Wang, Richard M. ; Brandon, Eugene P. ; Jaiman, Manasi S. ; Kroon, Evert J. ; D’Amour, Kevin A. ; Foyt, Howard L.</creator><creatorcontrib>Shapiro, A.M. James ; Thompson, David ; Donner, Thomas W. ; Bellin, Melena D. ; Hsueh, Willa ; Pettus, Jeremy ; Wilensky, Jon ; Daniels, Mark ; Wang, Richard M. ; Brandon, Eugene P. ; Jaiman, Manasi S. ; Kroon, Evert J. ; D’Amour, Kevin A. ; Foyt, Howard L.</creatorcontrib><description>These preliminary data from an ongoing first-in-human phase 1/2, open-label study provide proof-of-concept that pluripotent stem cell-derived pancreatic endoderm cells (PEC-01) engrafted in type 1 diabetes patients become islet cells releasing insulin in a physiologically regulated fashion. In this study of 17 subjects aged 22-57 with type 1 diabetes, PEC-01 cells were implanted subcutaneously in VC-02 macroencapsulation devices, allowing for direct vascularization of the cells. Engraftment and insulin expression were observed in 63% of VC-02 units explanted from subjects at 3–12 months post-implant. Six of 17 subjects (35.3%) demonstrated positive C-peptide as early as 6 months post-implant. Most reported adverse events were related to surgical implant or explant procedures (27.9%) or to side-effects of immunosuppression (33.7%). Initial data suggest that pluripotent stem cells, which can be propagated to the desired biomass and differentiated into pancreatic islet-like tissue, may offer a scalable, renewable alternative to pancreatic islet transplants. 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James</creatorcontrib><creatorcontrib>Thompson, David</creatorcontrib><creatorcontrib>Donner, Thomas W.</creatorcontrib><creatorcontrib>Bellin, Melena D.</creatorcontrib><creatorcontrib>Hsueh, Willa</creatorcontrib><creatorcontrib>Pettus, Jeremy</creatorcontrib><creatorcontrib>Wilensky, Jon</creatorcontrib><creatorcontrib>Daniels, Mark</creatorcontrib><creatorcontrib>Wang, Richard M.</creatorcontrib><creatorcontrib>Brandon, Eugene P.</creatorcontrib><creatorcontrib>Jaiman, Manasi S.</creatorcontrib><creatorcontrib>Kroon, Evert J.</creatorcontrib><creatorcontrib>D’Amour, Kevin A.</creatorcontrib><creatorcontrib>Foyt, Howard L.</creatorcontrib><title>Insulin expression and C-peptide in type 1 diabetes subjects implanted with stem cell-derived pancreatic endoderm cells in an encapsulation device</title><title>Cell reports. Medicine</title><addtitle>Cell Rep Med</addtitle><description>These preliminary data from an ongoing first-in-human phase 1/2, open-label study provide proof-of-concept that pluripotent stem cell-derived pancreatic endoderm cells (PEC-01) engrafted in type 1 diabetes patients become islet cells releasing insulin in a physiologically regulated fashion. In this study of 17 subjects aged 22-57 with type 1 diabetes, PEC-01 cells were implanted subcutaneously in VC-02 macroencapsulation devices, allowing for direct vascularization of the cells. Engraftment and insulin expression were observed in 63% of VC-02 units explanted from subjects at 3–12 months post-implant. Six of 17 subjects (35.3%) demonstrated positive C-peptide as early as 6 months post-implant. Most reported adverse events were related to surgical implant or explant procedures (27.9%) or to side-effects of immunosuppression (33.7%). Initial data suggest that pluripotent stem cells, which can be propagated to the desired biomass and differentiated into pancreatic islet-like tissue, may offer a scalable, renewable alternative to pancreatic islet transplants. [Display omitted] •Findings are shared for the first 17 participants in a phase 1/2 trial of VC-02•This investigational device was implanted into type 1 diabetes patients•VC-02 contains pluripotent stem cell-derived pancreatic endoderm cells•C-peptide levels and insulin expression correlate with engraftment in 63% of subjects Shapiro et al. report preliminary proof-of-concept that in 17 people with type 1 diabetes, pancreatic endoderm cells in an investigational subcutaneous device (VC-02) achieved engraftment and insulin expression in 63% of units at 3–12 months post-implant. 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Medicine</jtitle><addtitle>Cell Rep Med</addtitle><date>2021-12-21</date><risdate>2021</risdate><volume>2</volume><issue>12</issue><spage>100466</spage><epage>100466</epage><pages>100466-100466</pages><artnum>100466</artnum><issn>2666-3791</issn><eissn>2666-3791</eissn><abstract>These preliminary data from an ongoing first-in-human phase 1/2, open-label study provide proof-of-concept that pluripotent stem cell-derived pancreatic endoderm cells (PEC-01) engrafted in type 1 diabetes patients become islet cells releasing insulin in a physiologically regulated fashion. In this study of 17 subjects aged 22-57 with type 1 diabetes, PEC-01 cells were implanted subcutaneously in VC-02 macroencapsulation devices, allowing for direct vascularization of the cells. Engraftment and insulin expression were observed in 63% of VC-02 units explanted from subjects at 3–12 months post-implant. Six of 17 subjects (35.3%) demonstrated positive C-peptide as early as 6 months post-implant. Most reported adverse events were related to surgical implant or explant procedures (27.9%) or to side-effects of immunosuppression (33.7%). Initial data suggest that pluripotent stem cells, which can be propagated to the desired biomass and differentiated into pancreatic islet-like tissue, may offer a scalable, renewable alternative to pancreatic islet transplants. [Display omitted] •Findings are shared for the first 17 participants in a phase 1/2 trial of VC-02•This investigational device was implanted into type 1 diabetes patients•VC-02 contains pluripotent stem cell-derived pancreatic endoderm cells•C-peptide levels and insulin expression correlate with engraftment in 63% of subjects Shapiro et al. report preliminary proof-of-concept that in 17 people with type 1 diabetes, pancreatic endoderm cells in an investigational subcutaneous device (VC-02) achieved engraftment and insulin expression in 63% of units at 3–12 months post-implant. 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subjects Adolescent
Adult
Aged
C-Peptide - metabolism
Cells, Immobilized - cytology
Diabetes Mellitus, Type 1 - metabolism
Diabetes Mellitus, Type 1 - therapy
Endoderm - cytology
Female
Humans
Insulin - metabolism
Male
Middle Aged
Pancreas - cytology
Stem Cell Transplantation
Stem Cells - cytology
Young Adult
title Insulin expression and C-peptide in type 1 diabetes subjects implanted with stem cell-derived pancreatic endoderm cells in an encapsulation device
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