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Clinical trial

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

NCT06575426 is registered in ClinicalTrials.gov with Otsuka Pharmaceutical Factory, Inc. as lead sponsor.

NCT NCT06575426
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Registry record

As filed in ClinicalTrials.gov.

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
Lead sponsor
Otsuka Pharmaceutical Factory, Inc.
Phase
Phase 1/2
Overall status
Recruiting
Start date
June 10, 2025
Completion date
June 30, 2027
Enrollment
13 (estimated)
Sites
1

Conditions

As the registry lists them; a condition with its own page is linked.

autoimmune diseases, diabetes mellitus, type 1, glucose metabolism disorders (including diabetes mellitus), hypoglycemia, hypoglycemic episode, immune system diseases, islet cell transplantation, islet transplantation in diabetes mellitus type 1, metabolic disease, severe hypoglycemia, t1d, t1dm, t1dm - type 1 diabetes mellitus, type 1 diabetes, type 1 diabetes (t1d), type 1 diabetes mellitus, xenotransplantation