Islet Cell Transplantation Alone in Patients With Type I Diabetes Mellitus: Steroid-free Immunosuppression
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of islet cell transplantation in patients with Type 1 Diabetes Mellitus is to
      provide constant normal blood glucose levels. This may eliminate the need for insulin
      altogether or provide a significant reduction in the amount of insulin necessary to maintain
      constant normal blood glucose levels. This normalization may prevent or slow progression of
      diabetic complications. Furthermore, the participant may enjoy a healthier lifestyle and a
      better quality of life.

      If you meet the initial inclusion criteria for the trial, you must be able to give informed
      consent personally. Then you will need to participate in an extensive screening process that
      involves many standard tests and collection of laboratory samples to make sure that the
      transplant is suitable and safe for you.
    

Detailed description: 
      The trial may/will utilize the following immunosuppressive medications: tacrolimus
      (life-long), sirolimus (life-long), daclizumab and infliximab You will be maintained on the
      lowest doses possible with all the medications.

      GROUP (1A): The first four participants will be assigned to Group A. These participants will
      receive an islet cell transplant alone from two donors. They will receive the following
      immunosuppressive medications: tacrolimus (lifelong), sirolimus (lifelong), and daclizumab.
      They will not receive the immunosuppressive medication infliximab. GROUP (1B): The second
      four participants will be assigned to group B. These participants will receive an islet cell
      transplant alone from one donor. They will receive the following immunosuppressive
      medications: tacrolimus (lifelong), sirolimus (lifelong), daclizumab and infliximab. Patients
      in this group who are not able to stop injecting insulin by three months after the transplant
      may be eligible to receive a second islet cell transplant.

      Further participants will alternate group assignments in the same above-mentioned manner. The
      participants in both groups will receive the following immunosuppressive medications for
      life, tacrolimus and sirolimus. All participants will be required to live no more than two
      hours from the transplantation center.

      When the islets become available, you will be notified to come immediately to the hospital
      for your transplant. At that time numerous tests and laboratory samples will be performed to
      make sure you are ready and healthy for your transplant.

      You will have your islet cell transplant done in a special radiology procedure room in a
      hospital. You will have local anesthetic in the area of your liver on your right side along
      with sedatives that will minimize any discomfort the procedure might cause. A very small
      (thin) needle will be inserted through your liver into your portal vein where the islet cells
      are then injected.

      All participants will need to be followed at the Diabetes Research Institute after transplant
      for laboratory sampling, testing and for general islet cell transplant care.
    

Intervention name(s): islet cell transplantation
Intervention type(s): Procedure
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type I Diabetes Mellitus; Immunosuppression; Islet Cell Transplantation; PercutaneousTranshepaticPortalVein Catheterization