Long-term follow-up for patients with functional islet transplants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.