Islet Isolation Using MnTE-2-PyP (BMX-010) - Pilot Study
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      In this study, the investigators hypothesize that the addition of antioxidant BMX-010 to
      perfusion solution, digestion solution and culture medium during islet isolation process, can
      lead to greater preservation of islet mass and metabolic function, such as improved islet
      yield, viability, and functional potency.

      This pilot study will involve up to 10 participants from the islet transplant waiting list at
      the Clinical Islet Transplant Program. All participants will receive islets isolated with the
      medication BMX-010. This is to assess the primary safety of BMX-010 on pancreata and islets.
      BMX-010 will be used only in the islet isolation process, and will not be given to
      participants as medication.
    

Detailed description: 
      Islet Transplantation is a procedure used in people with difficult to control Type 1
      Diabetes. Insulin producing cells (islets) are isolated from a deceased donor pancreas. After
      the cells are carefully isolated from the donor pancreas, the islets are transplanted into
      the recipient's liver. These transplanted islets may produce insulin.

      One of the challenges with islet transplant is the death of some of the islet cells during
      isolation and storage while awaiting transplant. This is caused, in part, by inflammation and
      "oxidization" of the islet tissue. Oxidization is a process that causes chemical stress on
      living cells. We are looking for medications that would reduce inflammation, reduce
      oxidization and minimize cell death during the isolation process.

      BMX-010 is a new drug that we believe will help fight oxidization. It is an antioxidant that
      has been shown in lab studies to help islet cells survive isolation and keep them healthy and
      functioning. BMX-010 has not been used in human islet transplants in Canada before this
      study. BMX-010 has been used once in a patient who needed his pancreas removed - the islets
      were isolated and treated with BMX-010, then transplanted back into the patient (auto-islet
      transplant). These results are promising and there have been no significant side-effects
      reported. There have also been studies using human islets, treated with BMX-010, transplanted
      into mice.

      In this study, 10 patients will receive islets treated with BMX-010. This is to assess the
      primary safety of BMX-010 on pancreata and islets. For pancreata and islets treated with
      BMX-010, BMX-010 will be added in the steps of pancreas perfusion, pancreas digestion and
      islet culturing. Participants in the study will receive their islet transplants under
      standard of care islet transplant for all aspects of peri- and post-transplant management
      including immunosuppression. Islet transplant patients are followed as part of their standard
      of care, therefore the data collected for this study will be measured as part of routine
      clinical care, requiring no extra study specific clinic visits. We will review data collected
      up to day 30 post-transplant and will include the following: patient and graft survival data,
      biochemical data from routine blood work, routine and for cause imaging, metabolic testing,
      initiation of interventions to treat complications, and reporting of any adverse or serious
      adverse events.
    

Intervention name(s): Islet isolation using BMX-010
Intervention type(s): Drug
Intervention description(s): BMX-010 will be used as a supplement in islet isolation process.
Other intervention name(s): MnTE-2-PyP
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; Islet Transplant