If eligible, you may be asked to volunteer for a research study to determine the safety of an experimental treatment for Type I diabetes. Selected patients must have type 1 diabetes and also have poorly controlled diabetes with severe episodes of low blood sugar and normal kidney function. The purpose if this study is to determine the safety of transplanting isolated pancreatic islets which are clusters of cells that produce the hormone insulin that helps control blood sugar. A secondary goal is to determine whether a transplant of isolated pancreatic islet cells obtained from an organ donor to a diabetic patient’s liver can 1) improve the control of blood sugar, and /or, 2) reduce or eliminate the need for insulin injections, 3) reduce or eliminate hypoglycemic events.

To determine whether you are a suitable candidate for the study you will be evaluated in the University of Alabama at Birmingham by history and physical examination and collection of blood and urine specimens. Criteria for inclusion the Study as well as for Exclusion from the Study are given below:

1. Patient has been fully informed and has signed an IRB approved informed consent form and is willing and able to follow study procedures for the full 2 years.
2. Patient is a recipient of a primary islet transplant for type I diabetes of at least 5 years duration.
3. Patients with labile diabetes (characterized using mean amplitude of glycemic excursion (MAGE) and evidence of disruption of daily lifestyle) not rectified by a period of intensive insulin therapy (at least 6 months) and intensive glucose monitoring.
4. Patients with severe hypoglycemia events (requiring outside help to treat the hypoglycemia or documentation of capillary glucose values <3.0 mmol/l with minimal or no symptoms of hypoglycemia or primary neuroglycopenic symptoms) not rectified by a period of intensive insulin therapy and intensive glucose monitoring.
5. Patient is age 18-65 years
6. Body Mass index £ 26..
7. Female patients of child bearing potential must have a negative urine or serum pregnancy test upon hospitalization or within 7 days prior to enrollment and have agreed to utilize effective birth control throughout the study as well as for 6 weeks following study completion.

1. Patient has previously received or is receiving an organ transplant other than pancreatic islets.
2. Patient has renal dysfunction (> 1.2 mg/dl), macroproteinuria (protein <150 mg/dl), creatinine clearance < 45 ml/min).
3. Residual C-Peptide secretion (Mixed Meal Test, C-Peptide >0.2 ng/ml, see Appendix D).
4. Insulin requirements > 1.5 U/kg/day
5. Patient has type II diabetes.
6. Patient has liver dysfunction (ALT >56 U/L, AST >37 U/L, BT>1.0 g/DL).
7. Patient has unstable proliferative diabetic retinopathy.
8. Recipient has Addison’s disease or celiac disease as causes of labile diabetes.
9. Recipient or donor is seropositive for human immunodeficiency virus (HIV) or HbsAg positive serology.
10. Patient is pregnant or lactating.
11. History of a life-threatening contrast reaction.
12. Portal hypertension.
13. Active or chronic infections such as Hepatitis B or C.
14. Active gastric or duodenal ulcer.
15. Incorrigible coagulopathy (platelets <50,000 or INR > 1.5)
16. Psychosis.
17. Substance abuse
18. Positive tuberculosis skin reaction test
19. Gallbladder stones.
20. Non-compliance.
21. Neoplasia (if not free from relapse > 5 years).
22. Patient has Prostate Specific Antigen >4.
23. Patient has participated in a blinded trial or participated in a trial involving a non-marketed (investigational) drug within 3 months of enrollment.
24. Patient has > 20% panel reactive antibodies.
25. Other circumstances or conditions leading the transplant team to consider islet transplantation unsafe.