Trials / Recruiting
RecruitingNCT06575426
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
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 13 (estimated)
- Sponsor
- Otsuka Pharmaceutical Factory, Inc. · Industry
- Sex
- All
- Age
- 35 Years – 65 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2025-06-10
- Primary completion
- 2027-06-30
- Completion
- 2027-06-30
- First posted
- 2024-08-28
- Last updated
- 2026-03-02
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06575426. Inclusion in this directory is not an endorsement.