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Long Term Follow up of Recipients of Functional Islet Allografts

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study checks the long-term safety of donated islet cell transplants and how well they keep working. Islet cells are cells in the pancreas that make insulin. The study is for people who finished one of the earlier studies and still have a working transplant.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Took part in one of these earlier studies: 2000/0329, 2000/0196, 2004/0205, 2000/0024, 2006/0200, 2006/0508, or 2006/0210.
  • Have an islet cell transplant that still works and need medicines that keep the body from rejecting it.
  • Agree to use approved birth control during the study and for 4 months afterward.
  • Can give written consent to join the study.

Who can't join

  • For women: have a positive pregnancy test or are breastfeeding.
  • For men: plan to father a child during the study or within 4 months afterward.
  • Are unwilling to use effective birth control during the study and for 4 months afterward. Accepted methods include birth control pills, Norplant implants, Depo-Provera shots, or barrier methods with sperm-killing products. Condoms alone are not accepted.
  • Have a health condition that the study doctor thinks would make taking part unsafe.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

FL