Long Term Follow up of Recipients of Functional Islet Allografts

NCT01999374 | Recruiting

• 1 other identifier: 20130034
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Duration of sustained islet allograft function

  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.

  3 years

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subject with Type 1 diabetes mellitos status post islet transplantation

You may qualify if:

• 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 (absence of graft failure as defined in parent study) requiring immunosuppression.
• Willingness of participants to continue to use an approved method of contraception during and 4 months after study participation.
• Ability to provide written informed consent.

You may not qualify if:

• 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.
• Any medical condition that, in the opinion of the investigator, will interfere with safe participation in the trial.

Sponsors & Collaborators

• Rodolfo Alejandro: lead

Study Sites (1)

Diabetes Research Institute

Miami, Florida, 33136, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 33481552 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rodolfo Alejandro, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David A Baidal, MD

CONTACT

305 243-7740; dbaidal@med.miami.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 25, 2013
• First Posted: December 3, 2013
• Study Start: March 1, 2013
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

US (1)