Recruiting

Islet Allografts

Sponsor:

Rodolfo Alejandro

Code:

NCT01999374

Conditions

Type 1 Diabetes Mellitus

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT01999374

Start date

Mar, 2013

Status verified date

Mar, 2026

Completion date

Dec, 2029

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

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

Central Contacts and Locations

Central contacts

David A Baidal, MD

305 243-7740dbaidal@med.miami.edu

Locations

Diabetes Research Institute

Recruiting

Miami, Florida, United States, 33136

Contacts

Rodolfo Alejandro, MD

305-243-5321islet@med.miami.edu

Ana M Alvarez, APRN

305 243-3389axa383@med.miami.edu

Principal Investigator:

Rodolfo Alejandro, MD

More Information

Sponsor

Rodolfo Alejandro

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rodolfo Alejandro on 2026-03-23.