Study Results
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Basic Information
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COMPLETED
PHASE3
1 participants
INTERVENTIONAL
2006-04-30
Brief Summary
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Detailed Description
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In recent years, with the progress in composite tissue allotransplantation, there comes a new hope for the severely disfigured patients. The apparent success in human hand allotransplantation in the late 1990s laid the immunological and ethical groundwork for performing human facial allotransplantation and let surgeons consider the use of donor facial tissues for reconstructing severe facial deformities.The outcome of hand and forearm transplantation has been more successful than might have been predicted but nevertheless there has been a quite high incidence of rejection, in general controlled by additional immunosuppression, and there has also been chronic rejection seen in some of cases5. But facial transplantation, which will inevitably encounter many problems, is different from hand transplantation. Reports of the Royal College of Surgeons of England outlined the problems and potential down side of face transplantation, which including technical failure, acute rejection, chronic rejection, side effects of immunosuppressive therapy, noncompliance with immunosuppressive medication, psychologic and societal issues, ethical issues, et al.So Jean-Michel Dubernard said that face transplantation was much more difficult than the hand technically.
To solve these problems, many experts conducted related studies. Ulusal et al built the first facial/scalp flap transplantation model of rat. Cyclosporine A was used to prevent acute and chronic allograft rejections after the transplantation. Experts used animal facial transplantation models to study blood supply, tolerance induction, donor-specific chimerism, and medication. Cleveland Clinic Foundation carried out a series of studies on cadaver for facial allograft transplantation in preparation for facial transplantation in humans.Since 2002, we have been studying facial transplantation and have built a half facial transplantation model in rabbit . We chose Ciclosporin A, Azathioprine and Prednisone as immunosupressants and got a good result. Since the late 1990s, the progresses of these studies have strongly suggested that facial transplantation is bound to success.
In November 2005, the first partial facial transplantation was carried out successfully and got a good result in Amiens, France.
The recipient, a 30 years old man, came from a remote village of Yunnan province, China. His face was scratched by a bear in October 2004. Shortly after the disaster, he was treated by debridement and repaired with left forearm pedicle flap. But efficacy of these conventional techniques was not satisfactory and facial wounds did not heal, which seriously affected his appearance and function, and even his normal work and life. He was arranged to stay in hospital for further examinations and treatments on March 11, 2006.
The major defections on the patient's face involved extensive skin and soft tissue in the right buccal division combined with severe cicatricial contracture deformity, upper lip, total nose, the front wall of the right maxillary sinus, the lateral right orbital wall and infraorbital wall, the right zygomatic bone, a large portion of the right parotid gland.
Examinations showed panel reaction antibody (PRA) was very high (99% and 98% in two separate examinations), which implied the recipient belonged to the highly sensitive crowd. It is well known that highly sensitive patients with PRA often present with acute rejections. To decrease PRA and also the risk of surgery, immunoadsorption column of Protein A was used. Reexaminations showed that PRA was below 5% (in two separate examinations) before the surgery. Other medical examinations showed there were no surgical contraindications.
For this patient, traditional reconstructive procedures, including free skin graft, application of local flaps, tissue prefabrication, tissue expansion, and free tissue transfer, can only cover the wound. Without bony framework, reconstruction of the nose is too hard by traditional procedures. And the reconstruction of the upper lip is hard too. Face transplantation can be an appropriate operative indication for this patient..
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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III
The effect of human partial facial allotransplantation
human transplantation
Allograft composite tissue transplantation. procedure. medication
Interventions
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human transplantation
Allograft composite tissue transplantation. procedure. medication
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* donor: same boold type
* at least 3 sites were matched within 6 HLA sites
Exclusion Criteria
* donor: not the same boold type and 1 or 2 sites were matched within 6 HLA sites
18 Years
40 Years
MALE
No
Sponsors
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Xijing Hospital
OTHER
Responsible Party
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Xijing Hospital
Principal Investigators
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Shuzhong Guo, Dr
Role: STUDY_DIRECTOR
Xijing Hospital
Locations
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Xijing Hospital
Xi'an, Shaanxi, China
Countries
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References
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Dubernard JM, Lengele B, Morelon E, Testelin S, Badet L, Moure C, Beziat JL, Dakpe S, Kanitakis J, D'Hauthuille C, El Jaafari A, Petruzzo P, Lefrancois N, Taha F, Sirigu A, Di Marco G, Carmi E, Bachmann D, Cremades S, Giraux P, Burloux G, Hequet O, Parquet N, Frances C, Michallet M, Martin X, Devauchelle B. Outcomes 18 months after the first human partial face transplantation. N Engl J Med. 2007 Dec 13;357(24):2451-60. doi: 10.1056/NEJMoa072828.
Xudong Z, Shuzhong G, Yan H, Datai W, Yunzhi N, Linxi Z. A hemifacial transplantation model in rabbits. Ann Plast Surg. 2006 Jun;56(6):665-9. doi: 10.1097/01.sap.0000202829.24619.19. No abstract available.
Other Identifiers
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XJ-GuoSZ0709
Identifier Type: -
Identifier Source: org_study_id