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Implanted pluripotent stem-cell-derived pancreatic endoderm cells secrete glucose-responsive C-peptide in patients with type 1 diabetes
- Source :
- Cell Stem Cell; December 2021, Vol. 28 Issue: 12 p2047-2061.e5
- Publication Year :
- 2021
-
Abstract
- An open-label, first-in-human phase 1/2 study is being conducted to evaluate the safety and efficacy of pancreatic endoderm cells (PECs) implanted in non-immunoprotective macroencapsulation devices for the treatment of type 1 diabetes. We report an analysis on 1 year of data from the first cohort of 15 patients from a single trial site that received subcutaneous implantation of cell products combined with an immunosuppressive regimen. Implants were well tolerated with no teratoma formation or severe graft-related adverse events. After implantation, patients had increased fasting C-peptide levels and increased glucose-responsive C-peptide levels and developed mixed meal-stimulated C-peptide secretion. There were immunosuppression-related transient increases in circulating regulatory T cells, PD1highT cells, and IL17A+CD4+T cells. Explanted grafts contained cells with a mature β cell phenotype that were immunoreactive for insulin, islet amyloid polypeptide, and MAFA. These data, and associated findings (Shapiro et al., 2021), are the first reported evidence of meal-regulated insulin secretion by differentiated stem cells in patients.
Details
- Language :
- English
- ISSN :
- 19345909
- Volume :
- 28
- Issue :
- 12
- Database :
- Supplemental Index
- Journal :
- Cell Stem Cell
- Publication Type :
- Periodical
- Accession number :
- ejs58362115
- Full Text :
- https://doi.org/10.1016/j.stem.2021.10.003