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NCT number NCT03241719
Study type Interventional
Source Brigham and Women's Hospital
Contact Ericka M Bueno, PhD
Phone 6177327196
Email ebueno@bwh.harvard.edu
Status Recruiting
Phase Early Phase 1
Start date October 17, 2017
Completion date December 31, 2019

Clinical Trial 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.


Clinical Trial Description

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Study Design


Related Conditions & MeSH terms


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