The objective of this study is to develop a feasible and safe regimen for minimization of immune suppression in recipients of vascularized composite allotransplants (VCA) using a daily dose of recombinant IL-2. In order to achieve this aim, this trial will: 1. Perform VCA in 5 eligible subjects; 2. Administer recombinant IL-2 at a low-dose to promote the expansion and function of regulatory T cells in subjects who received VCA; and 3. Minimize immune suppression to tacrolimus single therapy in subjects who received VCA and recombinant IL-2. This trial will also investigate if it is possible to predict immune rejection in VCA using blood and tissue samples from recipients of VCA. Lastly, this trial will develop non-invasive technologies to monitor for VCA rejection. These technologies will involve magnetic resonance imaging. Multi-contrast ultra-high resolution MR imaging (MRI) with serial direct planimetry will be performed in recipients of VCA.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Subjects will receive vascularized composite allotransplantation (e.g. facial, hand and/or abdominal wall transplants) under conventional immune suppression. No sooner than 3 months after VCA, subjects will receive a protocol of daily recombinant IL-2 at low doses for 8 weeks.
Brigham and Women's Hospital
Boston, Massachusetts, United States
Number of regulatory T cells
Time frame: 4-24 months
Number of episodes of rejection
Time frame: 1-24 months
T-cell alloreactivity measured by ELISPOT
Time frame: 4-24 months
Steroid dose
Time frame: 6-24 months
Mycophenolate dose
Time frame: 8-24 months
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