A Study to Investigate Safety and Effectiveness of Porcine Pancreatic Cells (OPF-310) in Patients With Type 1 Diabetes Mellitus
This study tests a new treatment called OPF-310, which uses porcine (pig) pancreatic cells that are enclosed in a protective capsule and transplanted into patients with Type 1 diabetes. The goal is to determine if these cells can help control blood sugar levels and reduce the need for insulin injections. The study will also evaluate the safety of this new treatment approach.
Key Objective: OPF-310 aims to provide insulin-producing cells that could help regulate blood sugar levels and potentially reduce insulin dependence in people with unstable Type 1 diabetes.
Who to Consider: Adults with Type 1 diabetes who have difficulty managing their blood sugar levels despite using insulin may be candidates for this study.
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Subject must be aged 35 to 65 years of age inclusive, at the time of signing the informed consent. 2. Subject has an established diagnosis of type 1 diabetes mellitus (T1DM)(in accordance with the American Diabetes Association's criteria), with a minimum duration since diagnosis of 5 years. 3. If one of the following criteria (either a or b) applies: 1. Subject has unstable T1DM, not achieving adequate control after receiving CLS (CGM:Dexcom G6, insulin pump: Omnipod® 5 or t:slim X2) under care of a qualified diabetes team for at least 6 months prior to enrollment. 2. Subject has unstable T1DM, not achieving adequate control after receiving CLS (CGM:Dexcom G7, insulin pump: Omnipod® 5, t:slim X2, iLet Bionic Pancreas or The Tandem Mobi System) under care of a qualified diabetes team for at least 6 months prior to enrollment. 4. If one of the following criteria (either a, b or c) applies: 1. Subject has had a Level 3 (severe) hypoglycemic episode (defined as havin