Long-term follow-up for patients with functional islet transplants
Long Term Follow up of Recipients of Functional Islet Allografts
This study looks at how well islet transplants are working for people who had them in earlier trials, to see how they are doing over the long term.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT01999374 on ClinicalTrials.gov |
What this trial studies
This observational study aims to provide long-term follow-up for individuals who have received functional islet allografts as part of previous clinical trials. The Diabetes Research Institute will monitor approximately 30 subjects to assess the safety and efficacy of their islet transplants after they have completed their parent studies. Participants will be required to continue immunosuppressive medications and will be followed for any changes in graft function. The study seeks to gather additional data on the long-term outcomes of islet cell transplantation.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have previously participated in specific parent studies and currently have a functioning pancreatic islet graft.
Not a fit: Patients who have experienced graft failure or are not part of the specified parent studies will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the long-term viability and effectiveness of islet cell transplants in reversing Type 1 Diabetes.
How similar studies have performed: Previous studies on islet cell transplantation have shown promising results, indicating that this approach has potential based on earlier successes.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Miami, Florida
- Diabetes Research Institute — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Rodolfo Alejandro, MD — University of Miami
- Study coordinator: David A Baidal, MD
- Email: dbaidal@med.miami.edu
- Phone: 305 243-7740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.