Status: Recruiting
A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus
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.
Participants needed: 13
Trial details
Phase: Phase 1, Phase 2Age: 35-65Biological sex: AllType: InterventionalSponsor: Otsuka Pharmaceutical Factory, Inc.Updated: Mar 2, 2026Locations: 1
Eligibility criteria
Subject must be aged 35 to 65 years of age inclusive, at the time of signing the... [+11]
Previous history of insulin resistance (defined as an average insulin dose requi... [+32]