Selecting Islet Cell Clinical Trial Participants
Clinical Trial Qualifications
To be considered for enrollment in UW Health's islet cell clinical trial, patients must:
- Be between the ages of 18 and 60
- Have poorly controlled Type 1 diabetes
- Be ineligible for or not in favor of a standard pancreas transplant because of the associated surgical risks.
Specifically, patients must either have received a transplant at least six months ago and have had stable kidney function with no rejection episodes for at least the previous three months or have poor glycemic control and/or hypoglycemic unawareness, despite intensive insulin therapy, and have preserved native kidney function without progressive diabetic nephropathy.
Women of childbearing potential are not excluded from the trial but must have negative pregnancy test results. Because of the risk of immunosuppressive drugs to the fetus, women of childbearing potential must agree to follow effective contraceptive measures. Women must not breastfeed after transplant due to the potential adverse effects of the immunosuppressive drugs on the baby.
Additional Eligibility Requirements
In addition to the information above, the following is a summary of the characteristics patients must meet in order to be eligible for the islet transplant study trial:
- If the patient has not had a prior transplant, then s/he must have normal kidney function
- Poorly controlled blood sugars and/or life-threatening low blood sugar events which the patient can not anticipate
- Body mass index less than or equal to 28
- Absence of infection, cancer, hepatitis, or HIV
- Normal liver function