clinical trial · NCT06575426
A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus
Otsuka Pharmaceutical Factory, Inc.·phase2·recruiting·n = 13
Diabetes Mellitus, Type 1HypoglycemiaIslet Cell TransplantationType 1 DiabetesType 1 Diabetes MellitusT1DT1DMT1DM - Type 1 Diabetes MellitusOPF-310
brief summary
This study is First In Human study for Encapsulated Porcine Islet Cells for Xenotransplantation (OPF-310). The purpose of this study to assess the safety, tolerability, and efficacy of OPF-310 transplantation and to define the recommended Phase 2 dose (RP2D) in adult subjects with unstable Type 1 Diabetes Mellitus (T1DM) and a level 3 (severe) hypoglycemic episode at least three times within the 1 year prior to enrollment despite treatment with a closed loop system (CLS) for at least 6 months.
started
Jun 10, 2025
primary completion
Jun 30, 2027
completion
Jun 30, 2027
last updated
Mar 2, 2026
official title
A Phase I/IIa, Single Site, Open-Label, Ascending Dose Study to Evaluate the Safety and Efficacy of OPF-310 [Encapsulated Porcine Islet Cells for Xenotransplantation] in Subjects With Type 1 Diabetes Mellitus
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol