Long Term Follow up of Recipients of Functional Islet Allografts

Launched by RODOLFO ALEJANDRO · Nov 25, 2013

Keywords

ClinConnect Summary

This clinical trial, conducted by the Diabetes Research Institute (DRI), is focused on studying the long-term outcomes of individuals who have received islet cell transplants for Type 1 Diabetes. Islet cell transplants involve taking healthy insulin-producing cells from a donor's pancreas and placing them into a person with diabetes to help manage their blood sugar levels. The goal of this study is to collect information on the safety and effectiveness of these transplants over a longer period after participants have completed earlier related studies. Approximately 30 individuals who have successfully received islet transplants and are currently taking medications to prevent their bodies from rejecting the new cells are expected to join this trial.

To be eligible for the trial, participants must have previously taken part in one of the parent studies and currently have a functioning islet graft, meaning their transplanted cells are still working well. Participants should also be willing to use effective birth control methods during the study and for four months afterward. Throughout the trial, participants can expect regular follow-ups to monitor their health and the function of their transplanted cells. This important research will help improve our understanding of islet transplants and their long-term benefits for people living with Type 1 Diabetes.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Participation in any of the following parent studies: 2000/0329; 2000/0196; 2004/0205; 2000/0024; 2006/0200; 2006/0508; 2006/0210
• • 2. A functioning pancreatic islet graft (absence of graft failure as defined in parent study) requiring immunosuppression.
• • 3. Willingness of participants to continue to use an approved method of contraception during and 4 months after study participation.
• • 4. Ability to provide written informed consent.
• Exclusion Criteria:
• • 1. 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.
• • 2. Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.