Long Term Follow up of Recipients of Functional Islet Allografts

Conditions:Diabetes, Diabetes
Therapuetic Areas:Endocrinology
Age Range:18 - 65
Start Date:March 2013
End Date:December 2024

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Since its inception, the Diabetes Research Institute (DRI) has made significant contributions
to the field of diabetes, pioneering many of the techniques used in diabetes centers around
the world. Through several clinical trials, DRI has demonstrated that diabetes can be
successfully reversed as a result of islet cell transplant.

Over the years the following protocols in islet cell transplantation have been initiated:
2000/0329; 2000/0196; 2004/0205; 2000/024; 2006/0200; 2006/0508; 2006/0210.

All of the studies listed above will be source of study subjects for this study.
Approximately 30 subjects are expected to be enrolled and followed in this trial.

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

The purpose of this protocol is to collect additional follow-up for safety and efficacy from
subjects with graft function after their completion in their 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 parent

To provide long term follow up in subjects with functional islet allografts.

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.
We found this trial at
Miami, Florida 33136
Principal Investigator: Rodolfo Alejandro, MD
Phone: 305-243-5321
Miami, FL
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