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.
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.
- Candidates must be between the ages of 18 and 65
- Candidates must have had IDDM for at least 5 years and been under physician care for
at least 6 months prior to enrollment in trial.
- Eligible candidates will have poorly controlled insulin-dependent diabetes mellitus
(IDDM) and manifest signs and symptoms severe enough to be incapacitating. These
symptoms can include episodes of hypoglycemic unawareness (failure to recognize blood
glucose levels < 54 mg/dl) or episodes requiring the assistance of others.
- Candidates may have poor diabetes control despite intensive insulin therapy (HbA1c >
- Creatinine clearance should be > 60 ml/min)
- Body Mass Index should be less than 26
- Women of child-bearing age must have a negative pregnancy test and agree to follow
effective contraceptive measures for the duration of the trial.
- Previous or concurrent organ transplant
- Previous or concurrent malignancy
- Untreated proliferative diabetic retinopathy
- Unstable cardiovascular status, including positive stress echocardiography (if > age
- Active infections, including x-ray evidence of pulmonary infection
- Peptic ulcer disease, gall stones, or portal hypertension
- Abnormal liver function tests
- Presence of panel reactive antibodies > 20%
- Creatinine clearance < 60 ml/min
- HbA1c 12%
- Serological evidence of HIV, HbsAg, or HCV
- Anemia (hemoglobin < 12.0)
- Any condition or circumstance, including psychogenic factors, that preclude
therapeutic compliance or otherwise make it unsafe to undergo an islet cell
- PSA > 4 in males