Long Term Follow up of Recipients of Functional Islet Allografts
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.
Type 1 Diabetes Mellitus
|Study Design:||Time Perspective: Prospective|
|Official Title:||Long Term Follow up of Recipients of Functional Islet Allografts|
- Duration of sustained islet allograft function [ Time Frame: 3 years ] [ Designated as safety issue: No ]The primary endpoint is duration of sustained islet allograft function as determined by evidence from Mixed Meal Tolerance Test of c-peptide production. A c-peptide level >=0.3 ng/ml at 0, 60, or 90 minutes will be considered evidence of islet allograft function.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
To provide long term follow up in subjects with functional islet allografts.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01999374
|United States, Florida|
|Diabetes Research Institute||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Rodolfo Alejandro, MD 305-243-5321 firstname.lastname@example.org|
|Principal Investigator: Rodolfo Alejandro, MD|
|Principal Investigator:||Rodolfo Alejandro, MD||University of Miami|