RECRUITING

Long Term Follow up of Recipients of Functional Islet Allografts

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Long Term Follow up of Recipients of Functional Islet Allografts

Quick Facts

Study Start:2013-03
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT01999374

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Participation in any of the following parent studies: 2000/0329; 2000/0196; 2004/0205; 2000/0024; 2006/0200; 2006/0508; 2006/0210
  2. 2. A functioning pancreatic islet graft (absence of graft failure as defined in parent study) requiring immunosuppression.
  3. 3. Willingness of participants to continue to use an approved method of contraception during and 4 months after study participation.
  4. 4. Ability to provide written informed consent.
  1. 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. 2. Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.

Contacts and Locations

Study Contact

David A Baidal, MD
CONTACT
305 243-7740
dbaidal@med.miami.edu

Principal Investigator

Rodolfo Alejandro, MD
PRINCIPAL_INVESTIGATOR
University of Miami

Study Locations (Sites)

Diabetes Research Institute
Miami, Florida, 33136
United States

Collaborators and Investigators

Sponsor: Rodolfo Alejandro

  • Rodolfo Alejandro, MD, PRINCIPAL_INVESTIGATOR, University of Miami

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2013-03
Study Completion Date2027-12

Study Record Updates

Study Start Date2013-03
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Type 1 Diabetes Mellitus