CLINICAL AND TRANSLATIONAL RESEARCH First Human Face Transplantation: 5 Years Outcomes Palmina Petruzzo, 1,2,10 Sylvie Testelin, 3 Jean Kanitakis, 4 Lionel Badet, 1 Benoit Lengele ´, 5 Jean-Pierre Girbon, 6 He ´le `ne Parmentier, 7 Christophe Malcus, 8 Emmanuel Morelon, 1,9 Bernard Devauchelle, 2 and Jean-Michel Dubernard 1 Background. The first human facial allotransplantation, a 38-year-old woman, was performed on November 27, 2005. The aesthetic aspect and functional recovery and the risk-to-benefit ratio are evaluated 5 years later. Materials and Methods. The facial transplantation included nose, chin, part of cheeks, and lips. The immunosuppres- sive protocol included tacrolimus, mycophenolate mofetil, prednisone, and antithymocyte globulins. In addition, donor bone marrow cells were infused on days 4 and 11 after transplantation. Results. The aesthetic aspect is satisfying. The patient has normal protective and discriminative sensibility. She showed a rapid motion recovery, which has remained stable for 3 years posttransplantation. She can smile, chew, swallow, and blow normally whereas pouting and kissing is still difficult. Phonation recovery was impressive therefore the patient can talk normally. Two episodes of acute rejection developed during the first year. Donor-specific anti-human leukocyte antigen antibodies were never detected. Five-year mucosal biopsy showed a slight perivascular inflammatory infiltrate while skin biopsy was normal. The main side effect of the immunosuppressive treatment was a progressive decrease in renal function, which improved after switching from tacrolimus to sirolimus. Moreover, she developed arterial hypertension, an increase in lipid levels, and in situ cervix carcinoma treated by conization. Since 2008, she showed mild cholangitis possibly caused by sirolimus. In September 2010, bilateral pneumopathy occurred and was successfully treated with antibiotics. Conclusion. Despite some long-term complications, which are similar to those reported after solid organ transplan- tation, the patient is satisfied of her new face and has normal social interaction. Keywords: Face allotransplantation, Composite tissue allotransplantation, Functional recovery, Immunosuppression side-effects, Rejection. (Transplantation 2012;93: 236–240) F acial transplantation has been performed in disfigured patients to restore the aesthetic appearance and function when all the other conventional reconstructive techniques had failed or were expected to fail. It is important to remind that of all the physical handicaps, none is so socially devastat- ing as facial disfigurement, which may lead to depression, social isolation, alcohol abuse, and increased risk of suicide in the majority of cases. Indeed, facially disfigured patients ex- perience many psychologic and social problems, such as low- ered self-confidence, negative self-image, social anxiety, and marital problems (1). For all these reasons, we decided to perform the first face allotransplantation on November 27, 2005. Not only did the recipient, a young woman disfigured after an accident that resulted in the loss of part of the face, including nose and mouth, experience the disfigurement but also the impossibility to eat, drink, and speak normally. Thus, social interaction became problematic, resulting in tremen- dous psychologic and social difficulties. The patient accepted the risks of facial allotransplantation to gain functional, aes- thetic, and social benefits. The early outcome confirmed the technical feasibility of this new procedure and the immuno- suppressive regimen, which was the same used in hand trans- plantation with the addition of two infusions of donor bone marrow, assured graft survival (2). The evolution of the graft was favorable with a notable recovery of sensibility and mo- The authors declare no funding or conflicts of interest. 1 Department of Transplantation, Ho ˆ pital Edouard Herriot, HCL, Lyon, France. 2 Department of Surgery, University of Cagliari, Cagliari, Italy. 3 Service de Chirurgie Maxillofaciale et Stomatologie, CHU-Nord, Amiens, France. 4 Department of Dermatology, Ho ˆ pital Edouard Herriot, Lyon, France. 5 Experimental Morphology Department, Catholic University of Louvain, Brussels, Belgium. 6 Burns Unit, Ho ˆ pital Edouard Herriot, Lyon, France. 7 Institut des Sciences et Techniques de la Re ´adaptation, Claude Bernard Lyon I University, Lyon, France. 8 Department of Immunology, Ho ˆ pital Edouard Herriot, Lyon, France. 9 INSERM U 851, Universite ´ de Lyon, Lyon, France. 10 Address correspondence to: Palmina Petruzzo, M.D., Department of Transplan- tation, Ho ˆpital Edouard Herriot 5, place d’Arsonval, 69437 Lyon, France. E-mail: petruzzo@medicina.unica.it or palmina.petruzzo@chu-lyon.fr All the authors have collaborated, read, and approved the manuscript. B.L., S.T., and B.D. performed the surgical procedure. J.P.G. and H.P. evalu- ated sensibility and motion recovery in the follow-up. J.K. performed the biopsies and the histologic studies. The remaining authors managed the patient during the 5 years of follow-up. P.P. collected the data. P.P., J.K., and E.M. wrote the manuscript. J.M.D. and B.D. both have to be consid- ered as “last author” being the coordinator of the transplantation team and the maxilla-facial surgery team, respectively. Received 26 May 2011. Revision requested 17 June 2011. Accepted 14 October 2011. Copyright © 2012 by Lippincott Williams & Wilkins ISSN 0041-1337/12/9302-236 DOI: 10.1097/TP.0b013e31823d4af6 236 | www.transplantjournal.com Transplantation • Volume 93, Number 2, January 27, 2012