Long Term Surveillance of Islet Transplant Recipients Following Complete Graft Loss

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2028-07-31

Brief Summary

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This is a single-center, prospective, open label study in islet transplant recipients following islet graft loss.

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Detailed Description

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After complete islet graft loss is determined, patient's maintenance immunosuppression (i.e. sirolimus, tacrolimus, MMF and/or Myfortic®) will be discontinued and they will be monitored for 10 years thereafter, for the appearance of allosensitization using panel reactive antibody (PRA) levels and monitor the persistence of elevated PRA levels. Primary objective is to determine the rate of allosensitization in patients 3 years after failed islet transplantation (i.e. stimulated c-peptide \<0.3mg/mL) and monitor the persistence of elevated PRA levels (≥ 20%) at year 3, 6, and 9. Timing, frequency and level of change in PRA will be monitored after all immunosuppression is discontinued.

Conditions

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Type 1 Diabetes Mellitus

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

1\. History of at least one islet alone transplant (ie islet transplant in the absence of any other organ transplant).

Exclusion Criteria

1. Inability to provide written informed consent.
2. Mentally unstable and/or unable to comply with the procedures of the study protocol.
3. History of any solid organ transplant.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No