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B-Lymphocyte Immunotherapy in Islet Transplantation (CIT-05)

Who can participate?
In general, to participate in this study, one must be 18-65 years of age, diagnosed with type 1 diabetes before age 40 and insulin dependent for more than 5 years. There are more specific inclusion and exclusion criterion for participation in this study, which can be discussed with the study contact.
What is this study?
This study is one of seven studies being conducted by the Clinical Islet Transplant (CIT) Consortium, which is a network of clinical centers and a data coordinating center established in 2004 to conduct studies of islet transplantation in patients with type 1 diabetes.

Studies conducted by the CIT Consortium will focus on improving the safety and long-term success of methods for transplanting islets, the insulin-producing cells of the pancreas, in people whose own islets have been destroyed by the autoimmune process that characterizes type 1 diabetes.

Why is it being done?
The goals of the CIT studies are to:
  • improve the isolation and viability of islets;
  • reduce complications of the islet transplant procedure(e.g., bleeding and clotting in the blood vessels of the liver);
  • reduce the side effects of immunosuppression;
  • achieve good blood sugar control without hypoglycemia;
  • follow the fate of islets after transplantation and determine why donor islets sometimes fail; and
  • evaluate new ways to safely prevent immune rejection of donor tissues.

The goal of the CIT05 studies is to determine the proportion of subjects who are insulin independent at 75 ± 5 days following one islet cell infusion among subjects treated with an experimental islet transplant immunosuppression regimen which includes rituximab and excludes tacrolimus.

If I enroll in this study, what do I have to do?
Participants in this study will undergo an extensive screening process before being accepted for the study. The screening process will be a multi-faceted intensive medical evaluation. After the screening process is complete, participants will be told if they qualify for the study and asked if they wish to participate. Another study (CIT07) is also being conducted at this site. Participants who qualify for the study will be listed for an islet transplant, and randomly assigned to the CIT05 or CIT07 protocol. Once a donor is found, the transplant will occur. The time from listing to transplant can be lengthy.

The transplant procedure will require hospitalization. During this time, a participant will be given many medications to help the islets work. Additional testing will be done at specific time intervals after the transplant procedure. Additional islet transplants may be needed if specific results are not achieved.

Participants may be in the study for up to one year from the time of their final islet transplant. The length of time you will be in the study depends on which study you are in, how long you must wait for a transplant and how many transplants you receive.

Can I participate in other studies if I participate in this one?
You cannot participate in any other research studies in which treatments are given. However, it may be possible for you to participate in other kinds of studies that do not involve intervention.
How can I learn more?
See contact information below.


Pennsylvania


Contact Center
Phone: 1-877-IsletStudy
www.citisletstudy.org/
Last Updated: June 30, 2008

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