A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

June 10, 2025

Primary Completion Date

June 30, 2027

Study Completion Date

June 30, 2027

Conditions
Diabetes Mellitus, Type 1HypoglycemiaIslet Cell Transplantation
Interventions
COMBINATION_PRODUCT

OPF-310

"Dose(Part1): 6,000 islet equivalents (IEQ)/kg or 12,000 islet equivalents (IEQ)/kg~Dose(Part2): Recommended Phase II Dose(RP2D), which will be determined based on the data of Part1~* In Part1, three subjects will be enrolled into the first dosing cohort (Cohort 1: 6,000 IEQ/kg) and they will undergo safety monitoring. Three subjects in Cohort 2 will be dosed with 12,000 IEQ/kg and will undergo safety monitoring.~* In Part2, 7 subjects will be enrolled into the Part 2 dose-expansion part."

Trial Locations (1)

60612

RECRUITING

University of Illinois Hospital &Health Scences System, Chicago

All Listed Sponsors
lead

Otsuka Pharmaceutical Factory, Inc.

INDUSTRY