RecruitingPhase 1Phase 2NCT06575426

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

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

Sponsor

Otsuka Pharmaceutical Factory, Inc.

Enrollment

13 participants

Start Date

Jun 10, 2025

Study Type

INTERVENTIONAL

Conditions

Metabolic Disease Diabetes Mellitus, Type 1 Type 1 Diabetes Type 1 Diabetes Mellitus Immune System Diseases Hypoglycemia Autoimmune Diseases Glucose Metabolism Disorders (Including Diabetes Mellitus)Type 1 Diabetes (T1D)Severe Hypoglycemia T1D T1DM T1DM - Type 1 Diabetes Mellitus Islet Cell Transplantation Xenotransplantation Hypoglycemic Episode Islet Transplantation in Diabetes Mellitus Type 1

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.

Eligibility

Min Age: 35 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests the safety and effectiveness of a transplant of encapsulated pig (porcine) pancreatic cells (OPF-310) in people with type 1 diabetes whose blood sugar is very difficult to control despite using advanced insulin delivery systems. The pig cells produce insulin and could reduce or eliminate the need for insulin injections. **You may be eligible if...** - You are between 35 and 65 years old - You have had type 1 diabetes for at least 5 years - You still have unstable blood sugar despite using a closed-loop insulin pump and continuous glucose monitor system for at least 6 months - You are not achieving adequate blood sugar control under the care of a diabetes specialist **You may NOT be eligible if...** - Your diabetes is well-controlled on current devices - You have been diagnosed for fewer than 5 years - You fall outside the 35–65 age range - You have serious other health conditions that would make the procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

COMBINATION_PRODUCTOPF-310

Dose(Part1): 6,000 islet equivalents (IEQ)/kg or 12,000 islet equivalents (IEQ)/kg Dose(Part2): Recommended Phase II Dose(RP2D), which will be determined based on the data of Part1 * In Part1, three subjects will be enrolled into the first dosing cohort (Cohort 1: 6,000 IEQ/kg) and they will undergo safety monitoring. Three subjects in Cohort 2 will be dosed with 12,000 IEQ/kg and will undergo safety monitoring. * In Part2, 7 subjects will be enrolled into the Part 2 dose-expansion part.