Long Term Follow up of Recipients of Functional Islet Allografts

NCT ID: NCT01999374

Last Updated: 2025-01-27

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-03-31
• Study Completion Date: 2028-12-31

Brief Summary

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.

Detailed Description

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

Conditions

Type 1 Diabetes Mellitus

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rodolfo Alejandro

OTHER

Sponsor Role: lead

Responsible Party

Rodolfo Alejandro

Professor of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Rodolfo Alejandro, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

Diabetes Research Institute

Miami, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David A Baidal, MD

Role: CONTACT

dbaidal@med.miami.edu

305 243-7740

Facility Contacts

Rodolfo Alejandro, MD

Role: primary

islet@med.miami.edu

305-243-5321

Ana M Alvarez, APRN

Role: backup

axa383@med.miami.edu

305 243-3389

References

Rios P, Baidal D, Lemos J, Camhi SS, Infante M, Padilla N, Alvarez Gil AM, Fuenmayor V, Ambut J, Qasmi FA, Mantero AM, Cayetano SM, Ruiz P, Ricordi C, Alejandro R. Long-term Persistence of Allosensitization After Islet Allograft Failure. Transplantation. 2021 Nov 1;105(11):2490-2498. doi: 10.1097/TP.0000000000003635.

Reference Type: DERIVED

PMID: 33481552 (View on PubMed)

Other Identifiers

20130034

Identifier Type: -

Identifier Source: org_study_id