Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in VCA
Status:
Terminated
Trial end date:
2021-07-21
Target enrollment:
Participant gender:
Summary
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.