NCT01999374 · Rodolfo Alejandro
Long Term Follow up of Recipients of Functional Islet Allografts
What this study is about
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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Miami, Florida
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 23, 2026 · Source of record for eligibility and locations