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Long Term Follow up of Recipients of Functional Islet Allografts
NCT01999374 · University of Miami
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
About this study
To provide long term follow up in subjects with functional islet allografts.
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.
Study design
Enrollment target: 30 participants
Age groups: adult, older_adult
Timeline
Starts: 2013-03
Estimated completion: 2029-12
Last updated: 2026-03-23
Primary outcomes
- • Duration of sustained islet allograft function (3 years)
Sponsor
Rodolfo Alejandro · other
Contacts & investigators
ContactDavid A Baidal, MD · contact · dbaidal@med.miami.edu · 305 243-7740
InvestigatorRodolfo Alejandro, MD · principal_investigator, University of Miami
All locations (1)
Diabetes Research InstituteRecruiting
Miami, Florida, United States