Study of OPF-310 for Type 1 Diabetes Mellitus
This study is testing a new treatment called OPF-310, which uses porcine (pig) pancreatic cells, for people with unstable Type 1 Diabetes Mellitus. The main goal is to see how safe and effective OPF-310 is, and to figure out the best dose for future studies. You might be able to join if you are 35 to 65 years old, have had Type 1 diabetes for at least 5 years, and have experienced severe low blood sugar (hypoglycemia) multiple times in the past year, even with a closed-loop insulin system. The study will measure how many participants reach a specific treatment goal one year after receiving the transplant. This is a "first-in-human" study, meaning it's the first time this treatment is being given to people.
- Study design
- This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 13 participants to assess the safety and effectiveness of OPF-310.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for one year after the transplant to measure the main treatment goal.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Percentage of Subjects Reaching the Efficacy GoalOne year after transplant
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.