NCT03241719

Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in VCA

Novel Strategies to Improve Immunomodulation and Non-invasive Clinical Monitoring in Vascularized Composite Allotransplantation

• Status: Terminated
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Brigham and Women's Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Amputation, Traumatic
• Amputation;Traumatic;Old
• Face Injury
• Face; Deformity
• Abdominal Wall Defect

Interventions

Type	Name	Description
DRUG	IL-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.

Timeline

• Start date: 2017-10-17
• Primary completion: 2021-07-21
• Completion: 2021-07-21
• First posted: 2017-08-07
• Last updated: 2021-07-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study