Actively Recruiting
Long Term Follow up of Recipients of Functional Islet Allografts
Led by Rodolfo Alejandro · Updated on 2026-03-23
30
Participants Needed
1
Research Sites
874 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 study.
CONDITIONS
Official Title
Long Term Follow up of Recipients of Functional Islet Allografts
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participation in any of the following parent studies: 2000/0329; 2000/0196; 2004/0205; 2000/0024; 2006/0200; 2006/0508; 2006/0210
- A functioning pancreatic islet graft (no graft failure as defined in parent study) requiring immunosuppression
- Willingness to use an approved contraception method during and for 4 months after the study
- Ability to provide written informed consent
You will not qualify if you...
- For females: positive pregnancy test, currently breastfeeding, or unwillingness to use effective contraception during the study and for 4 months after
- For males: intent to father a child during the study or for 4 months after, or unwillingness to use effective contraception
- Use of condoms alone as contraception is not acceptable
- Any medical condition that the investigator believes would interfere with safe participation in the trial
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Diabetes Research Institute
Miami, Florida, United States, 33136
Actively Recruiting
Research Team
D
David A Baidal, MD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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