https://bio.nikkeibp.co.jp/atcl/news/p1/25/04/15/13201/
https://orizuru-therapeutics.com/en/newsroom/20250415124/
Kyoto University Hospital and T-CiRA’s Orizuru have completed transplantation of the first patient with allogeneic iPS cell-derived islet cells in a physician-initiated clinical trial.
Orizuru Therapeutics is a startup developing regenerative medicine derived from allogeneic iPS cells and was established in April 2021 with the aim of commercializing projects outside of Takeda Pharmaceutical’s priority areas as part of the joint research project “T-CiRA” between Kyoto University’s Center for iPS Cell Research and Application (CiRA) and Takeda Pharmaceutical. The company is developing regenerative medicine using cardiomyocytes (OZTx-556) and pancreatic islet cells (OZTx-410) using iPS cells from the Kyoto University iPS Cell Research Foundation (CiRA_F). Orizuru has announced on April 15, 2025 that they have completed transplantation of the first patient in a physician-initiated clinical trial of transplanting allogeneic iPS cell-derived islet cells into a patient with type 1 diabetes(development number: OZTx-410).
OZTx-410 is a product made by inducing differentiation of allogeneic iPS cells into islet cells, including beta cells, and processing them into sheets. By processing them into sheets, it is said that it is easier for iPS cell-derived beta cells to engraft subcutaneously. This investigator-initiated clinical trial is a single-arm, open-label study in which OZTx-410 will be transplanted into patients with type 1 diabetes, equivalent to a phase 1/1b clinical trial. Immunosuppressants and insulin will be administered in combination with the transplantation of islet cells.
Safety will be evaluated primarily, with efficacy as a secondary evaluation, and continued observation will be conducted after the one-year primary evaluation period. Kyoto University Hospital submitted a clinical trial plan to the Pharmaceuticals and Medical Devices Agency (PMDA) in September 2024. The registration number in the Clinical Research Submission and Publication System (jRCT) is jRCT2053240146.
Three transplants are planned, and the first of these has now been completed. The transplant recipient is a woman in her 40s who was diagnosed with type 1 diabetes in 2001 and was receiving insulin treatment. The patient has already been discharged from the hospital, and will be monitored for up to five years through outpatient care. In a press release dated April 15, 2025, Kyoto University Hospital commented, “One month after the transplant, it was determined that there were no major safety issues, and we are preparing to transplant the second patient.”
