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

Recruiting now · Phase 1/Phase 2

Conditions studied: Diabetes Mellitus, Type 1, Hypoglycemia, Islet Cell Transplantation, Type 1 Diabetes, Type 1 Diabetes Mellitus, T1D, T1DM, T1DM - Type 1 Diabetes Mellitus, Type 1 Diabetes (T1D), Severe Hypoglycemia, Xenotransplantation, Hypoglycemic Episode, Islet Transplantation in Diabetes Mellitus Type 1, Glucose Metabolism Disorders (Including Diabetes Mellitus), Immune System Diseases, Autoimmune Diseases, Metabolic Disease

In brief

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.

Key facts

Study ID: NCT06575426
Run by: Otsuka Pharmaceutical Factory, Inc.
People needed: 13
Starts: 2025-06-10
Expected to finish: 2027-06-30
Last updated by the study team: 2026-03-02

Who can join

Age: 35 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.
If one of the following criteria (either a or b) applies:
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.
If one of the following criteria (either a, b or c) applies:
Subject has had a Level 3 (severe) hypoglycemic episode (defined as having cognitive impairment requiring external assistance for recovery) at least three times within the 1 year prior to enrollment recorded in the medical record or patient log.
Subject has had a Level 3 (severe) hypoglycemic episode at least once within the 1 year prior to enrollment and demonstrates a Clarke Score ≥4, assessed by trained study personnel. The SHE(s) and Clarke Score must be recorded in the medical record or patient log.
Subject has had TBR >1% at glucose levels below 70mg/dL and demonstrates a Clarke Score≥4, assessed by trained study personnel. TBR data used for screening and Clarke score must be recorded in the medical record or patient log.
Subject has C-peptide <0.3 ng/mL following a mixed meal tolerance test or undetectable fasting C-peptide.
Hemoglobin A1C (HbA1c) ≤ 9.0
Contraceptive use must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
Subject who can agree to cooperate with lifetime follow-up after transplantation.
Subject is capable of providing signed informed consent

You may not qualify if…

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.
History of malignancies within the past 5 years, excluding basal and squamous cell carcinoma
Positive serologies or nucleic acid testing for human immunodeficiency virus (HIV), hepatitis C, and hepatitis B.
Active or untreated proliferative diabetic retinopathy. Subjects may be rescreened once they are successfully treated.
Serious comorbid conditions that are likely to affect participation in the study, including:
Within the last 12 months, peripheral vascular disease with previous amputation.
History of New York Heart Association (NYHA) class II, III or IV congestive heart failure (CHF) and/or chronic atrial fibrillation.
Chronic obstructive pulmonary disease (COPD) or asthma with previous hospitalization for decompensation; a requirement for mechanical ventilation at any stage; or long- term treatment with oral corticosteroids.
Macroalbuminuria (> 300 mg albumin/gm creatinine).
Estimated glomerular filtration rate (eGFR) cut-off of < 30 ml/min for all per Kidney Disease Improving Global Outcomes (KDOQI) and Kidney Disease Outcomes Quality Initiative (KDIGO) consensus.
Use of warfarin or other anticoagulant therapy (except aspirin), or prothrombin time and international normalized ratio (PT-INR) > 1.5
Adrenal insufficiency being treated with corticosteroids
Previous pan-peritonitis
Previous cardiovascular or cerebrovascular disease. NOTE: For the purposes of this exclusion criterion, "previous cardiovascular disease" is defined as the presence of co-existing cardiac disease, characterized by any of the following conditions:
Recent myocardial infarction (within past one year), or
Angiographic evidence of non-correctable coronary artery disease, or
Evidence of ischemia on functional cardiac exam (with a stress echo test recommended for subjects with a history of ischemic disease), or
Heart failure > NYHAII
Patients with hematopoietic stem cell abnormalities (e.g., aplastic anemia, myelodysplastic syndrome)
Patients who received a blood transfusion in the previous 90 days, are anticipated to undergo surgery during the 1-year study period that may require transfusion, or have donated blood within the previous 90 days.
Previous receipt of an organ, skin allograft, or other tissue transplant from an allogeneic human or animal donor.
Treatment with immunosuppressive medication.

Where it is running

University of Illinois Hospital & Health Sciences System — Chicago, Illinois, United States (enrolling)

Full record on ClinicalTrials.gov

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