HITS - Human Islet Transplantation in Seattle
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Patient Participation

  Patients who are interested in receiving islet transplantation sponsored by the HITS program should contact their physician to review together the current protocol. We have completed the first phase of islet-only and simultaneous kidney-islet transplants. Currently, we are conducting only islet-after-kidney procedures. The islets-after-kidney transplantation protocol involves individuals who have had a successful kidney transplant and who do not take steroids but who have poor glucose control. The inclusion and exclusion criteria for this protocol are listed below.

ISLETS AFTER KIDNEY

Subject Inclusion Criteria
  1. Type 1 insulin-dependent diabetes > 10 years
  2. Prior successful kidney transplant
  3. Not on steroid therapy for maintenance immunosuppression
  4. No history of prolonged high dose steroid use within one year of transplantation
  5. Patients who have failed intense insulin therapy under the guidance of an endocrinologist
  6. Patient must have hypoglycemia unawareness with metabolic lability
  7. Age > 18 < 65
  8. C-peptide negative (< 0.5 ng/ml)
  9. PRA < 20%
  10. Patient is capable of understanding the purposes and risks of the study and of signing a statement of informed consent for each element of the study
  11. Women who are of child bearing potential must have a negative serum pregnancy test prior to transplant
Subject Exclusion Criteria
  1. Severe co-existing cardiac disease such as
    • Recent MI (within the past 6 months) or
    • Non-correctable coronary artery disease by angiogram
  2. Duration of diabetes < 10 years
  3. Age < 18 or > 65
  4. PRA > 20%
  5. Positive pregnancy test
  6. Anemia; Hct < 25%
  7. Severe insulin resistance, insulin requirements more than 0.7 U/kg
  8. C-peptide response to arginine stimulation (5gm IV) > 0.3 ng/ml at 2, 3, 4, 5, 7 and 10 minutes)
  9. Active infection, including hepatitis B, C, HIV or TB
  10. Active peptic ulcer disease
  11. History of or anticipated noncompliance
  12. Active alcohol or substance abuse, includes cigarette smoking (must be abstinent for 6 months)
  13. Obesity (i.e.: body mass index > 28)
  14. Any history or current malignancies except for squamous or basal skin cancer
  15. Hepatitis (chronic or active) or portal hypertension, abnormal liver function
  16. Gallstones or hepatic hemangiomas
  17. Allergy or sensitive to contrast agents
  18. Enrolled in another, simultaneous investigational protocol other than islets after kidney
  19. Hypercoagulative state or disorder requiring uninterrupted anticoagulation therapy
  20. Use of coumadin or other anticoagulant therapy or subject with PT-INR > 1.5
  21. Under treatment for a medical condition requiring chronic steroid use
  22. Addison's Disease
  23. HgbA1C > 12%
  24. Hyperlipidemia (treated or untreated fasting LDL > 130 mg/dl, and / or fasting triglycerides > 200 mg/dl.)
  25. Untreated proliferative retinopathy
  26. Allergy to heparin