NCT01281267|CompletedDMC
Face Transplantation for Treatment of Severe Facial Deformity
Transplantation of Allograft Face or Facial Subunit for Treatment of Severe Facial Deformation
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Transplantation of Allograft Face or Facial Subunit for Treatment of Severe Facial Deformation
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · Department of Defense
interventional
10
1 country
1
Study Start
September 1, 2009
Actual (reported)Primary Completion
October 31, 2019
Actual (reported)Study Completion
November 12, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 12, 2019
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 1, 2009
Actual (reported)January 20, 2011
Actual (reported)January 21, 2011
Actual (reported)October 31, 2019
Actual (reported)November 12, 2019
Actual (reported)Outcomes of face transplantation.
We will undertake an objective evaluation of the results of face transplantation in an 'outcome-oriented study'.
Subjects will be followed for 18 months after face transplantation
Efficacy and optimization of the immune suppression protocol.
18 months
Procedural outcomes of face transplantation
From subject recruitment to 18 months after transplantation
Functional outcomes of face transplantation
Subjects will be followed for 18 months following face transplantation
Psychosocial outcomes of face transplantation
Subjects will be followed up for 18 months following face transplantation
Financial and economic aspects of face transplantation
Subjects will be followed for 18 months after face transplantation
Facial allograft transplantation surgery is the transfer of face tissue from a deceased human donor to a patient with a severe facial deformity.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Brigham & Women's Hospital
Boston, Massachusetts, 02115, United States
Pomahac B, Aflaki P. Composite tissue transplantation: a new era in transplantation surgery. Eplasty. 2010 Sep 15;10:e58.
Aflaki P, Nelson C, Balas B, Pomahac B. Simulated central face transplantation: age consideration in matching donors and recipients. J Plast Reconstr Aesthet Surg. 2010 Mar;63(3):e283-5. doi: 10.1016/j.bjps.2009.08.013. Epub 2009 Sep 13. No abstract available.
Pomahac B, Aflaki P, Nelson C, Balas B. Evaluation of appearance transfer and persistence in central face transplantation: a computer simulation analysis. J Plast Reconstr Aesthet Surg. 2010 May;63(5):733-8. doi: 10.1016/j.bjps.2009.01.078. Epub 2009 Apr 23.
Bohdan Pomahac, MD
Brigham and Women's Hospital
First Submitted
January 20, 2011
First Posted
January 21, 2011
Study Start
September 1, 2009
Actual (reported)Primary Completion
October 31, 2019
Actual (reported)Contact the study team to confirm eligibility.
Kiwanuka H, Bueno EM, Diaz-Siso JR, Sisk GC, Lehmann LS, Pomahac B. Evolution of ethical debate on face transplantation. Plast Reconstr Surg. 2013 Dec;132(6):1558-1568. doi: 10.1097/PRS.0b013e3182a97e2b.
Lamparello BM, Bueno EM, Diaz-Siso JR, Sisk GC, Pomahac B. Face time: educating face transplant candidates. Eplasty. 2013 Jul 4;13:e36. Print 2013.
Soga S, Ersoy H, Mitsouras D, Schultz K, Whitmore AG, Powers SL, Steigner ML, Signorelli J, Prior RF, Rybicki FJ, Pomahac B. Surgical planning for composite tissue allotransplantation of the face using 320-detector row computed tomography. J Comput Assist Tomogr. 2010 Sep-Oct;34(5):766-9. doi: 10.1097/RCT.0b013e3181e9c133.
Pomahac B, Pribaz J, Eriksson E, Annino D, Caterson S, Sampson C, Chun Y, Orgill D, Nowinski D, Tullius SG. Restoration of facial form and function after severe disfigurement from burn injury by a composite facial allograft. Am J Transplant. 2011 Feb;11(2):386-93. doi: 10.1111/j.1600-6143.2010.03368.x. Epub 2011 Jan 7.
Edrich T, Pomahac B, Lu JT, Couper GS, Gerner P. Perioperative management of partial face transplantation involving a heparin antibody-positive donor. J Clin Anesth. 2011 Jun;23(4):318-21. doi: 10.1016/j.jclinane.2010.07.004.
Pomahac B, Nowinski D, Diaz-Siso JR, Bueno EM, Talbot SG, Sinha I, Westvik TS, Vyas R, Singhal D. Face transplantation. Curr Probl Surg. 2011 May;48(5):293-357. doi: 10.1067/j.cpsurg.2011.01.003. No abstract available.
Pomahac B, Lengele B, Ridgway EB, Matros E, Andrews BT, Cooper JS, Kutz R, Pribaz JJ. Vascular considerations in composite midfacial allotransplantation. Plast Reconstr Surg. 2010 Feb;125(2):517-522. doi: 10.1097/PRS.0b013e3181c82e6f.
Saavedra AP, Bueno EM, Granter SR, Pomahac B. Transmission of donor-specific skin condition from donor to recipient of facial allograft. Am J Transplant. 2011 Jun;11(6):1340. doi: 10.1111/j.1600-6143.2011.03596.x. No abstract available.
Kumamaru KK, Sisk GC, Mitsouras D, Schultz K, Steigner ML, George E, Enterline DS, Bueno EM, Pomahac B, Rybicki FJ. Vascular communications between donor and recipient tissues after successful full face transplantation. Am J Transplant. 2014 Mar;14(3):711-9. doi: 10.1111/ajt.12608. Epub 2014 Feb 6.
Lian CG, Bueno EM, Granter SR, Laga AC, Saavedra AP, Lin WM, Susa JS, Zhan Q, Chandraker AK, Tullius SG, Pomahac B, Murphy GF. Biomarker evaluation of face transplant rejection: association of donor T cells with target cell injury. Mod Pathol. 2014 Jun;27(6):788-99. doi: 10.1038/modpathol.2013.249. Epub 2014 Jan 17.
Sinha I, Pomahac B. Split rejection in vascularized composite allotransplantation. Eplasty. 2013 Oct 8;13:e53.
Schultz K, George E, Mullen KM, Steigner ML, Mitsouras D, Bueno EM, Pomahac B, Rybicki FJ, Kumamaru KK. Reduced radiation exposure for face transplant surgical planning computed tomography angiography. PLoS One. 2013 Apr 26;8(4):e63079. doi: 10.1371/journal.pone.0063079. Print 2013.
Pomahac B, Bueno EM, Sisk GC, Pribaz JJ. Current principles of facial allotransplantation: the Brigham and Women's Hospital Experience. Plast Reconstr Surg. 2013 May;131(5):1069-1076. doi: 10.1097/PRS.0b013e3182865cd3.
Win TS, Crisler WJ, Dyring-Andersen B, Lopdrup R, Teague JE, Zhan Q, Barrera V, Ho Sui S, Tasigiorgos S, Murakami N, Chandraker A, Tullius SG, Pomahac B, Riella LV, Clark RA. Immunoregulatory and lipid presentation pathways are upregulated in human face transplant rejection. J Clin Invest. 2021 Apr 15;131(8):e135166. doi: 10.1172/JCI135166.
Aycart MA, Alhefzi M, Sharma G, Krezdorn N, Bueno EM, Talbot SG, Carty MJ, Tullius SG, Pomahac B. Outcomes of Solid Organ Transplants After Simultaneous Solid Organ and Vascularized Composite Allograft Procurements: A Nationwide Analysis. Transplantation. 2017 Jun;101(6):1381-1386. doi: 10.1097/TP.0000000000001262.
Borges TJ, O'Malley JT, Wo L, Murakami N, Smith B, Azzi J, Tripathi S, Lane JD, Bueno EM, Clark RA, Tullius SG, Chandraker A, Lian CG, Murphy GF, Strom TB, Pomahac B, Najafian N, Riella LV. Codominant Role of Interferon-gamma- and Interleukin-17-Producing T Cells During Rejection in Full Facial Transplant Recipients. Am J Transplant. 2016 Jul;16(7):2158-71. doi: 10.1111/ajt.13705. Epub 2016 Apr 7.
Soga S, Pomahac B, Mitsouras D, Kumamaru K, Powers SL, Prior RF, Signorelli J, Bueno EM, Steigner ML, Rybicki FJ. Preoperative vascular mapping for facial allotransplantation: four-dimensional computed tomographic angiography versus magnetic resonance angiography. Plast Reconstr Surg. 2011 Oct;128(4):883-891. doi: 10.1097/PRS.0b013e3182268b43.
Study Completion
November 12, 2019
Actual (reported)Last Updated
January 27, 2021
Record last verified: 2021-01
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