Health Trials

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

ConditionsDiabetes Mellitus, Type 1HypoglycemiaIslet Cell TransplantationType 1 DiabetesType 1 Diabetes MellitusT1DT1DMT1DM - Type 1 Diabetes MellitusType 1 Diabetes (T1D)Severe HypoglycemiaXenotransplantationHypoglycemic EpisodeIslet Transplantation in Diabetes Mellitus Type 1Glucose Metabolism Disorders (Including Diabetes Mellitus)Immune System DiseasesAutoimmune DiseasesMetabolic Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age35-65
SponsorOtsuka Pharmaceutical Factory, Inc.

About this trial

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

Qualifiers

Subject must be aged 35 to 65 years of age inclusive, at the time of signing the informed consent.

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.

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.

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.

Disqualifiers

Previous history of insulin resistance (defined as an average insulin dose requirement ≥ 0.8 unit/kg/day for 1 week prior to enrollment).

Subject has latent autoimmune diabetes in adults (LADA), ketosis-prone (Flatbush) diabetes, or maturity onset diabetes of the young (MODY).

CRP ≥ 10 mg/L.

Clinically unstable thyroid disease (thyroid stimulating hormone (TSH)< the lower limit of the normal range of TSH at the site.) Patients with subclinical hyperthyroidism can be rescreened once TSH levels normalize due to treatment or other factors. In addition, patients with transiently abnormal TSH levels may undergo rescreening only once during the screening period.

Trial design

Treatments tested in this trial

  • OPF-310

Treatment groups

13 Participants
are divided into 1 treatment group

Locations

1
University of Illinois Hospital & Health Sciences System60612, ChicagoIllinois, United States

Sponsors and collaborators

Otsuka Pharmaceutical Factory, Inc.

Lead sponsor

Source ClinicalTrials.gov