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

NCT03241719 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2021-07-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Bohdan Pomahac, MD · Brigham and Women's Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-17
Primary Completion
2021-07-21
Completion
2021-07-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03241719 on ClinicalTrials.gov