1. Encapsulated stem cell–derived β cells exert glucose control in patients with type 1 diabetes.
- Author
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Keymeulen, Bart, De Groot, Kaat, Jacobs-Tulleneers-Thevissen, Daniel, Thompson, David M., Bellin, Melena D., Kroon, Evert J., Daniels, Mark, Wang, Richard, Jaiman, Manasi, Kieffer, Timothy J., Foyt, Howard L., and Pipeleers, Daniel
- Abstract
Clinical studies on the treatment of type 1 diabetes with device-encapsulated pancreatic precursor cells derived from human embryonic stem cells found that insulin output was insufficient for clinical benefit. We are conducting a phase 1/2, open-label, multicenter trial aimed at optimizing cell engraftment (ClinicalTrials.gov identifier: NCT03163511). Here we report interim, 1-year outcomes in one study group that received 2–3-fold higher cell doses in devices with an optimized membrane perforation pattern. β cell function was measured by meal-stimulated plasma C-peptide levels at 3-month intervals, and the effect on glucose control was assessed by continuous glucose monitoring (CGM) and insulin dosing. Of 10 patients with undetectable baseline C-peptide, three achieved levels ≥0.1 nmol l
−1 from month 6 onwards that correlated with improved CGM measures and reduced insulin dosing, indicating a glucose-controlling effect. The patient with the highest C-peptide (0.23 nmol l−1 ) increased CGM time-in-range from 55% to 85% at month 12; β cell mass in sentinel devices in this patient at month 6 was 4% of the initial cell mass, indicating directions for improving efficacy. β cells derived from stem cells improve blood glucose control in patients with diabetes. [ABSTRACT FROM AUTHOR]- Published
- 2024
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