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