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A breakthrough cell therapy may offer a new approach to type 1 diabetes by reducing dependence on urgent, donor-dependent procedures. This study was presented at the European Association for the Study of Diabetes Congress 2025

Clinical-grade biodegradable cell sheets (OZTx-410) containing induced pluripotent stem cell-derived pancreatic islet cells were successfully implanted between the fascia and parietal peritoneum under general anesthesia and fixed with absorbable sutures. Patients received a standard immunosuppressive regimen, including recombinant anti-thymocyte globulin for induction and tacrolimus plus mycophenolate mofetil for maintenance.

The procedure demonstrated initial safety and feasibility, and the implanted cells retained viability and functional characteristics. The ongoing open-label, single-center, dose-escalation trial will further evaluate long-term safety, glycemic control, functional efficacy, and potential optimization of OZTx-410. If successful, this approach could provide an elective, off-the-shelf alternative to conventional pancreatic islet transplantation, improving accessibility and treatment flexibility for patients with type 1 diabetes.

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Key highlights
  • Human induced pluripotent stem cells were differentiated into pancreatic endocrine progenitors and embedded in biodegradable cell sheets.
  • The first transplantation was successfully performed in a patient with type 1 diabetes using standard islet transplantation immunosuppression.
  • This dose-escalation study aims to evaluate safety, efficacy, and optimization of the therapy in subsequent cases.
Source

Nakamura T, Fujikura J, Keidai Y, et al. First-in-human case: allogeneic transplantation of human induced pluripotent stem cell-derived islet cells in a patient with type 1 diabetes. Presented at: 61st EASD Annual Meeting of the European Association for the Study of Diabetes; September 15-19, 2025; Vienna, Austria. Diabetologia. 2025:167. https://link.springer.com/article/10.1007/s00125-025-06497-1#Sec28 

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	First Transplantation of Off-the-Shelf Stem Cell-Derived Pancreatic Islet Therapy Completed
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Short Description

iPSC-derived pancreatic islet cell sheets offer a potential elective treatment for type 1 diabetes.
 

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