The purpose of this study is to provide patients who have received at least one islet transplant as a previous participant in a Clinical Islet Transplantation Consortium (CIT) clinical trial with maintenance immunosuppressive medications and to collect information about the safety of the medications and islet function.
Extended Follow-Up After Islet Transplantation in Type 1 Diabetes (CIT-08)
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.
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.
You CAN'T join if...
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.
University of California, San Francisco San Francisco, California, 94143, United States
University of Minnesota Minneapolis, Minnesota, 55455, United States
University of Illinois Chicago, Illinois, 60612, United States
Northwestern University Chicago, Illinois, 60611, United States
Emory University Atlanta, Georgia, 30322, United States
University of Pennsylvania Philadelphia, Pennsylvania, 19104, United States
University of Miami Miami, Florida, 33136, United States
Massachusetts General Hospital Boston, Massachusetts, 02493, United States
accepting new patients by invitation only
National Institute of Allergy and Infectious Diseases (NIAID)