The main objective of this trial is to determine whether islet cell transplantation (ICT) using anti-thymocyte globulin (ATG) is a safe and effective treatment for type I diabetes. The main outcome to be measured is number of patients who no longer need insulin therapy following transplantation. This trial is being held in Duarte, California.
The details
ICT is a procedure that involves transplanting islet cells (cells that produce insulin) removed from a donor pancreas into a patient for growth and development of new insulin producing cells. One of the major risks with ICT is that the body will reject these cells, as the immune system (protects again disease and foreign illnesses) will recognize them as 'foreign agents' to attack. ATG is a combination of antibodies (cells that fight disease) that fight against the immune cells. They are used in the prevention and treatment of rejection in patients that receive transplantation.
The aim of this trial is to determine whether ICT, using ATG to stop the immune response, is a safe and effective treatment in patients with type 1 diabetes. The main outcome will be number of patients who no longer require insulin therapy, with normalized blood glucose levels.
Who are they looking for?
This trial will recruit 30 type 1 diabetes patients between the ages of 18 and 68 years. Three categories of patients will be included.
1. Those who have not had any type of transplant and who have experienced frequent hypoglycemia (dangerously low blood glucose) or are unaware of hypoglycemia when it happens.
2. Those who have undergone a failed pancreas transplant more than 6 months prior to screening or two or fewer ICTs more than 1 month prior to screening.
3. Those who have undergone a successful renal transplant more than 3 months prior to screening. Patients who are currently receiving stable maintenance immunosuppression drugs (drugs that stop the immune response) and have no history or a low risk of rejection will be considered for this trial.
Patients who have a body mass index (BMI - measure of body fat based on height and weight) more than 30 or patients who require more than 1.2 kg/units of insulin per day will not be eligible. Patients who have a history of illnesses or diseases that may influence their participation in the trial will not be eligible. These include heart disease, liver/gallbladder or bile duct disease, high risk of bleeding, acute infections or viral infections, mental illness or alcohol/drug abuse. Women who are currently trying to get pregnant or who are pregnant will not be eligible for this trial. Patients who have used vaccines within 2 months of the trial or who have used investigational drugs within 1 month of the trial will not be eligible.
How will it work
Patients will receive an ICT into the liver, with a maximum of three ICTs. These patients will be followed for a period of five years. Blood sugar levels, islet transplant function and changes in quality of life will be monitored.
