Extended Follow-Up After Islet Transplantation in T1D

After islet-cell transplantation in the CIT studies*, each subject receives maintenance
immunosuppressive medications.

The purpose of this protocol is to collect additional follow-up for safety and efficacy from
CIT subjects with graft function after their completion in their CIT parent study. It is
expected that most subjects will retain measurable islet function and, in the islet-alone
studies, continue to receive immunosuppressive medications at the time of completing their
CIT parent study.

*CIT parent studies: CIT02 (NCT00464555), CIT03 (NCT00434850), CIT04 (NCT00468403), CIT05
(NCT00468442), CIT06 (NCT00468117), and CIT07 (NCT00434811)

Inclusion Criteria:

- Subjects who have received an islet transplant during participation in the following
Clinical Islet Transplantation (CIT) parent studies: CIT02 (NCT00464555), CIT03
(NCT00434850), CIT04 (NCT00468403), CIT05 (NCT00468442), CIT06 (NCT00468117), and
CIT07 (NCT00434811)

- A functioning pancreatic islet graft (e.g., absence of graft failure as defined in
parent study) requiring immunosuppression

- Willingness of participants to continue to use an approved method of contraception
during and 4 months after study participation

- Ability to provide written informed consent

- Resident of the United States of America

- Documentation of the existence or lack of health insurance coverage and whether
immunosuppressants are covered.

Exclusion Criteria:

- For female subjects-Positive pregnancy test, presently breast-feeding, or
unwillingness to use effective contraceptive measures for the duration of the study
and 4 months after discontinuation

- For male subjects-Intent to procreate during the duration of the study or within 4
months after discontinuation or unwillingness to use effective measures of
contraception. Oral contraceptives, Norplant®, Depo-Provera®, and barrier devices with
spermicide are acceptable contraceptive methods; condoms used alone are not
acceptable.

- Received an islet transplant in a non-CIT research study

- Any medical condition that, in the opinion of the investigator, will interfere with
safe participation in the trial.