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NCT06575426 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus
A Phase 1 study of Type 1 Diabetes and Diabetes Mellitus, Type 1, sponsored by Otsuka Pharmaceutical Factory.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 13
- Enrollment target
- 1
- Study location
NCT06575426 is a Phase 1 study of Type 1 Diabetes and Diabetes Mellitus, Type 1 that is actively recruiting participants, run by Otsuka Pharmaceutical Factory. The registered enrollment target is 13 participants, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06575426, a Phase 1 study of Type 1 Diabetes and Diabetes Mellitus, Type 1, is actively recruiting participants, sponsored by Otsuka Pharmaceutical Factory.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 13 participants
- Enrollment target
- 1
- Study location
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 Studied
Interventions
- COMBINATION_PRODUCT OPF-310
Study Locations (1)
Illinois
- University of Illinois Hospital & Health Sciences System - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2025-06-10 |
| Est. Completion | 2027-06-30 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06575426
The ClinicalTrials.gov registry entry for NCT06575426 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 13 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 824-participant average among 178 other Type 1 Diabetes trials with a reported enrollment target (98% lower). The listed sponsor is Otsuka Pharmaceutical Factory, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 10 conditions, with Type 1 Diabetes appearing as the primary indexed condition, and to 1 intervention - of which OPF-310 is the first listed.
NCT06575426 reports 1 study location spanning 1 distinct geographic area - top geographies include Illinois.
Frequently Asked Questions
What is clinical trial NCT06575426 about?
NCT06575426 is a clinical study titled "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 Di...
What is the current status of trial NCT06575426?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 13 participants. The study started on 2025-06-10. Estimated completion is 2027-06-30.
What conditions does trial NCT06575426 study?
This clinical trial studies the following conditions: Type 1 Diabetes, Diabetes Mellitus, Type 1, Type 1 Diabetes Mellitus, Hypoglycemia, Type 1 Diabetes (T1D).
What interventions are being tested in trial NCT06575426?
The interventions under investigation include: OPF-310 (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT06575426?
This trial is sponsored by Otsuka Pharmaceutical Factory, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06575426 being conducted?
This trial has 1 study location across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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