The main objective of this trial is to determine the safety and effectiveness of transplanting islet cells (pancreas cells that produce insulin) onto the omentum (skin that forms the stomach lining and connects the stomach to other abdominal organs). The main outcome will be the number of patients who achieve normal blood glucose levels without complications. This trial is recruiting in Miami, Florida (US).
The details
Transplanting islet cells in to the liver has been shown to stabilize blood sugar levels, preventing them from becoming too low in patients with type 1 diabetes. However, transplanting cells from one area of the body to another may trigger an immune system response (attacking the cells the way it would a virus or bacteria). To prevent this, drugs that stop the immune system from working must be used. Transplanting these cells into the omentum allows for islet cells to attach more securely and function more adequately.
The main aim of this trial is to determine patient safety and whether transplanting these cells will reduce the risk of low blood sugar levels and will stabilize HbA1c levels (average blood gluocose over 3 months).
Who are they looking for?
This trial will recruit 6 patients aged 18 to 65 years. Patients must have developed type 1 diabetes before the age of 40. Patients must have been insulin dependent for more than 5 years. Patients must have had at least one episode of severely low blood levels in the past 12 months.
Patients who require more than 1.0 IU/kg or less than 15 U/day of insulin will not be considered eligible. Patients with an HbA1c of more than 10% or high blood pressure will not be considered for this trial. Patients with a history of kidney disease, active infection or disease (such as hepatitis B, C, HIV or other viruses or heart, liver or stomach diseases), cancers, or alcohol/substance abuse will not be considered for this trial. Patients who are currently pregnant or trying to conceive and who are not taking contraceptive methods will not be eligible. Patients who have used steroids or anti-diabetic medication other than insulin 4 weeks prior to enrollment will not be considered. Any patients on drugs that block the immune response or who have received previous islet transplants will not be considered.
How will it work
All patients will be treated with medications that stop the immune response. Patients will undergo islet transplantation of at least 5000 cells into the omentum. HbA1c levels will be measured at 1 year. Episodes of severely low blood sugar levels will be monitored from Day 28 to Day 365 after surgery.
