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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: Recruiting Phase 1 study of Type 1 Diabetes and Diabetes Mellitus, Type 1, sponsored by Otsuka Pharmaceutical Factory.
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 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A successful primary endpoint was defined as achieve both an HbA1c \< 7 % and a reduction of at least 0.5% from baseline, and absence of a Level 3 (severe) hypoglycemic episode from 12 weeks to 52 weeks post-transplant.
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 |
What NCT06575426 shows while recruiting
NCT06575426 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 767-participant average among 198 other Type 1 Diabetes trials with a reported enrollment target (98% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06575426's enrollment target sits among peer trials
13 173rd of 198 higher than 24 of 198 other Type 1 Diabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 1 Diabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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