Long Term Follow up of Recipients of Functional Islet Allografts

Part of paid clinical trials in Miami, Florida.

Sponsor
Rodolfo Alejandro
Study ID
NCT01999374
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Mar 31, 2013
Status verified
Mar 2026
Primary completion
Mar 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
30 participants (estimated)

Primary Outcome Measure

Duration of sustained islet allograft function [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Diabetes Research InstituteMiamiFlorida33136
Rodolfo Alejandro, MD
[email protected]
305-243-5321
Ana M Alvarez, APRN
[email protected]
305 243-3389
Rodolfo Alejandro, MD (PRINCIPAL_INVESTIGATOR)
David A Baidal, MD (SUB_INVESTIGATOR)

Find similar trials in Miami, FL

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Diabetes Research Institute· Miami, FL

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