This study being carried out in Illinois will evaluate the safety of islet transplants in patients with hard to control type 1 diabetes. Donor islet cells will be injected into the patients and blood glucose levels will be monitored for one year after the transplant. Success will be based on the efficacy and safety of the treatment.
The details
A normal pancreas contains islet cells which produce insulin needed to break down glucose (sugar). Patients with type 1 diabetes lack the islet cells needed to produce insulin and require insulin therapy. Patients with “brittle” type 1 diabetes find it very difficult to control their blood glucose levels despite insulin therapy. This increases the risk of many complications including kidney and heart damage. Islet cell transplants may hold the answer to improving glucose control for these patients, without the need for insulin injections. This trial will investigate the safety and efficacy of islet cell transplants.
Who are they looking for?
This study will recruit 10 adult patients under the age of 70 with uncontrolled type 1 diabetes. Patients must have diabetes for at least 5 years and must be monitoring their blood glucose levels at least 3 times per day and injecting insulin 3 or more times per day or using an insulin pump. Despite this intensive treatment patients must have had one episode of dangerously low blood glucose (hypoglycemia) in the past 12 months.
Patients will be excluded from the study if they are obese or weigh under 50 kg. Female patients must not be pregnant or breast feeding, and all patients must agree to use suitable contraception for the duration of the study and 4 months after stopping the trial. Patients with infections or patients abusing alcohol or other substances will also be excluded.
How will it work
Patients will receive an injection of islet cells directly into their veins. To prevent the immune system attacking these islet cells all patients will receive drugs to dampen the immune response, such as infliximab (Remicade) or mycophenolatemofetil (Cellcept). Blood glucose levels will be monitored for 1 year after the injection to determine the efficacy and safety of the transplant.
