NCT01999374 Long Term Follow up of Recipients of Functional Islet Allografts
| NCT ID | NCT01999374 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rodolfo Alejandro |
| Condition | Type 1 Diabetes Mellitus |
| Study Type | OBSERVATIONAL |
| Enrollment | 30 participants |
| Start Date | 2013-03 |
| Primary Completion | 2028-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 30 participants in total. It began in 2013-03 with a primary completion date of 2028-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Rodolfo Alejandro, MD
PRINCIPAL INVESTIGATOR
University of Miami
Frequently Asked Questions
Who can join the NCT01999374 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Type 1 Diabetes Mellitus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01999374 currently recruiting?
Yes, NCT01999374 is actively recruiting participants. Contact the research team at dbaidal@med.miami.edu for enrollment information.
Where is the NCT01999374 trial being conducted?
This trial is being conducted at Miami, United States.
Who is sponsoring the NCT01999374 clinical trial?
NCT01999374 is sponsored by Rodolfo Alejandro. The principal investigator is Rodolfo Alejandro, MD at University of Miami. The trial plans to enroll 30 participants.
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