Recruiting

NCT Number: NCT01999374

Long Term Follow up of Recipients of Functional Islet Allografts

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.

Recruiting

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Diabetes Research Institute

Miami, Florida, 33136, United States

Location status: Recruiting

Location contact

Ana M Alvarez, APRN

CONTACT

[email protected]

305 243-3389

David A Baidal, MD

SUB_INVESTIGATOR

Rodolfo Alejandro, MD

CONTACT

[email protected]

305-243-5321

Rodolfo Alejandro, MD

PRINCIPAL_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

Duration of sustained islet allograft function

Time frame: 3 years

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.

Study contacts

Contact information is provided by the study sponsor or research team.

David A Baidal, MD

CONTACT

[email protected]

305 243-7740

Sponsors and collaborators

Lead sponsor

Rodolfo Alejandro

Other

Registry information

Important dates

Study start: 2013
Primary completion: 2028
Study completion: 2029
First posted: Dec 3, 2013
Registry last updated: Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting