A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus
Public ClinicalTrials.gov record NCT06575426. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT06575426
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 13 participants
Conditions and interventions
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
Eligibility (public fields only)
- Age range
- 35 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 9, 2025
- Primary completion
- Jun 29, 2027
- Completion
- Jun 29, 2027
- Last update posted
- Aug 20, 2026
2025 – 2027
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Illinois Hospital & Health Sciences System | Chicago | Illinois | 60612 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06575426, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 20, 2026 · Synced Sep 6, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06575426 live on ClinicalTrials.gov.