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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Otsuka Pharmaceutical Factory, Inc.
Study ID
NCT06575426
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
35 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • OPF-310 — COMBINATION_PRODUCT
    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.

Study Details

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.

Key Dates

Start date
Jun 10, 2025
Status verified
Feb 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
13 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: OPF-310
    13 patients will be transplanted OPF-310.

Primary Outcome Measure

Percentage of Subjects Reaching the Efficacy Goal [ Time Frame: One year after transplant ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Illinois Hospital & Health Sciences SystemChicagoIllinois60612
Benito Valdepenas
[email protected]
312-355-3113

Find similar trials in Chicago, IL

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
University of Illinois Hospital & Health Sciences System· Chicago, IL

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