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 transplanted islets
due to inflammation, oxidative stress and exposure to diabetogenic immunosuppressive agents
associated with islet functional impairment and graft loss, especially linked to the use of
calcineurin inhibitors, including tacrolimus (Tac).
Antiaging glycopeptide (PKX-001) is a small, stable, synthetic replica of antifreeze proteins
(AFPs), which naturally occur in Arctic and Antarctic fish and have been shown protecting
cells against harmful conditions. PKX-001 is a new drug that has been shown in lab studies to
help islet cells survive isolation and keep them healthy and functioning. Most importantly,
animal studies have shown that islets treated with PKX-001 were protected from the
immunosuppressant (Tac) toxicity and retained their function in animals receiving islet
transplant.
This study will involve up to 10 participants from the islet transplant waiting list at the
Clinical Islet Transplant Program. All participants will receive islets treated with the
medication PKX-001. PKX-001 will be used only in the islet preservation process, and will not
be given to participants as medication.
The purpose of this study is to confirm the safety of transplantation of PKX-001 treated
islets and to evaluate the cytoprotective capacity of PKX-001 in islet transplantation,
especially its capacity to protect against Tac induced graft dysfunction.