Islet Cell Transplantation

Clinical Research Program

For Healthcare Professionals

NewYork-Presbyterian Hospital/Weill Cornell Medical Center has established an exciting new treatment, islet cell transplantation for patients with type 1 diabetes, and is currently in the process of evaluating candidates for this research study.

Our islet transplantation program is modeled after the highly successful islet transplantation protocol developed by the researchers in Edmonton, Canada, who have had unsurpassed success in making islet cell transplant recipients insulin-free for prolonged periods of time after islet transplantation. The most recent data from the Edmonton group suggests that 80% of recipients are off of insulin one year after their transplant. The success observed at Edmonton has inspired several transplant centers throughout the United States, including ours, to develop an islet cell transplant program that incorporates several of the features responsible for the success observed with the Edmonton protocol.

In islet cell transplantation, islet cells are removed from the donor's pancreas and the cells are then injected into the portal vein of the patient's liver, where they are able to enter the liver and produce insulin (see diagram below). The patient is usually required to be in the hospital for only one or two days after the injection of islet cells.

Islet cell transplant recipients will need to take immunosuppressant medications in order to protect the islet cells from destruction by the immune system. Patients will receive daclizumab, tacrolimus, and sirolimus to prevent rejection, as well as other medications to prevent opportunistic infection. Patients will need to take the immunosuppressive medications for as long as the islet cells continue to work.

In addition, two or three separate islet cell infusions may be necessary in order for the patient to become insulin independent. Because of that, the patient may still be required to take insulin after the first transplant, although the amount of insulin needed will be much less than the amount taken prior to transplant.

There are some risks associated with this experimental procedure that will be explained in great detail to those patients who enter the evaluation process. These include, but are not limited to, thrombosis, bleeding, infection, post-transplant lymphoproliferative disease, and adverse effects of the transplant medications.

Patients may be a candidate for islet cell transplantation if they:

• Have had type 1 diabetes for more than 5 years, and
• Experience hypoglycemic unawareness, or
• Have been hospitalized several times in the past year for hypoglycemia and/or hyperglycemia, or
• Have complications of diabetes such as retinopathy, nephropathy, or neuropathy

Patients will not be a candidate for islet cell transplantation if they:

• Are less than 18 years of age or more than 65 years of age
• Have type 2 diabetes
• Have progressed to end-stage kidney disease

Please download this [PDF file] for a complete list of inclusion and exclusion criteria for islet cell transplant research.

The screening process involves several steps, outlined below:

1. Endocrinologist or primary care physician will be asked to fill out a questionnaire as an initial assessment of their patient's potential to become an islet candidate
2. If the patient fulfills the basic inclusion and exclusion criteria found in the questionnaire, the patient will then be invited to come to the hospital for further screening. This screening process includes:
   • Laboratory tests (such as serum chemistries, CBC, lipid profile, blood typing, viral studies, 24-hour urine)
   • Diabetes-related testing such as mixed meal test and arginine stimulation test
   • Meeting with transplant social worker
   • Other diagnostic tests (electrocardiogram, chest x-ray, liver ultrasound, cardiac stress test)
   • Routine follow-up with physicians that the patient would normally see on a regular basis (dentist, gynecologist, ophthalmologist)

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