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

NCT06575426 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-03-02

No results posted yet for this study

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.

Conditions

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

Interventions

COMBINATION_PRODUCT

OPF-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.

Sponsors & Collaborators

  • Otsuka Pharmaceutical Factory, Inc.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-10
Primary Completion
2027-06-30
Completion
2027-06-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06575426 on ClinicalTrials.gov