Condition: Diabetes Mellitus, Type 1 · Hypoglycemia · Islet Cell Transplantation · Sponsor: Otsuka Pharmaceutical Factory, Inc.
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.
This description comes directly from the study's public registry record.
For participant-focused inquiries, please contact: · 847-500-9204 · opf-310_autoreply@opf-america.com
For physician or professional inquiries, please contact: · 847-200-6731 · opf-310_project_team@opf-america.com
Always discuss trial participation with your own doctor first.
| University of Illinois Hospital & Health Sciences System | Chicago, Illinois, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06575426