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.