NCT01281267

Face Transplantation for Treatment of Severe Facial Deformity

Completed NA Last updated 27 January 2021

What this trial tests

NA trial testing Facial Allograft Transplantation in Severe Facial Deformity in 10 participants. Completed in 12 November 2019.

Timeline

1 September 2009

Primary endpoint
31 October 2019

12 November 2019

Quick facts

Lead sponsor	Brigham and Women's Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	1 September 2009
Primary completion	31 October 2019
Estimated completion	12 November 2019
Sites	1 location across United States

Drugs / interventions tested

• Facial Allograft Transplantation

Conditions studied

• Severe Facial Deformity — all drugs for Severe Facial Deformity →

Sponsor

Brigham and Women's Hospital

Who can join

Adults 18 to 60, any sex, with Severe Facial Deformity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Face transplantation surgery is the transfer of face tissue from a deceased human donor to a patient with a severe facial deformity. Face transplantation is an innovative reconstructive procedure that has the potential to significantly improve the lives of patients with severe facial injuries. The purpose of this study is to develop the best practices for facial transplantation that will improve the outcomes of future face transplant recipients.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Codominant Role of Interferon-γ- and Interleukin-17-Producing T Cells During Rejection in Full Facial Transplant Recipients.
   Borges TJ, O'Malley JT, Wo L, Murakami N, et al · · 2016 · cited 29× · PMID 26749226 · DOI 10.1111/ajt.13705
2. Immunoregulatory and lipid presentation pathways are upregulated in human face transplant rejection.
   Win TS, Crisler WJ, Dyring-Andersen B, Lopdrup R, et al · · 2021 · cited 22× · PMID 33667197 · DOI 10.1172/jci135166
3. Longitudinal immunological characterization of the first presensitized recipient of a face transplant.
   Win TS, Murakami N, Borges TJ, Chandraker A, et al · · 2017 · cited 20× · PMID 28679959 · DOI 10.1172/jci.insight.93894
4. Increased levels of circulating MMP3 correlate with severe rejection in face transplantation.
   Kollar B, Shubin A, Borges TJ, Tasigiorgos S, et al · · 2018 · cited 18× · PMID 30297859 · DOI 10.1038/s41598-018-33272-7
5. The residual STL volume as a metric to evaluate accuracy and reproducibility of anatomic models for 3D printing: application in the validation of 3D-printable models of maxillofacial bone from reduced radiation dose CT images.
   Cai T, Rybicki FJ, Giannopoulos AA, Schultz K, et al · · 2015 · cited 18× · PMID 30050971 · DOI 10.1186/s41205-015-0003-3
6. Blood proteome profiling using aptamer-based technology for rejection biomarker discovery in transplantation.
   Shubin AV, Kollar B, Dillon ST, Pomahac B, et al · · 2019 · cited 15× · PMID 31819064 · DOI 10.1038/s41597-019-0324-y
7. Noninvasive vascular images for face transplant surgical planning.
   Soga S, Wake N, Bueno EM, Steigner ML, et al · · 2011 · cited 7× · PMID 22184509
8. Reduced radiation exposure for face transplant surgical planning computed tomography angiography.
   Schultz K, George E, Mullen KM, Steigner ML, et al · · 2013 · cited 6× · PMID 23638180 · DOI 10.1371/journal.pone.0063079