Clinical Trial

A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus

Recruiting Phase 1/2
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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.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2024-08-26; most recent amendment 2026-02-26.
Status change: Not Yet Recruiting → Recruiting 2025-03-17
Trial Details
NCT Number NCT06575426
Lead Sponsor Otsuka Pharmaceutical Factory, Inc.
Conditions Diabetes Mellitus, Type 1, Hypoglycemia, Islet Cell Transplantation, Type 1 Diabetes, Type 1 Diabetes Mellitus, T1D, T1DM, T1DM - Type 1 Diabetes Mellitus +9 more
Enrollment 13 participants
Start Date 2025-06-10
Primary Completion 2027-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-02