Human Partial Facial Allotransplantation
Condition: Pharmaceutical Preparations
Study type: Interventional
Phase: Phase 3

Summary: 
      Progress in composite tissue allotransplantation provides a new remedy for severely
      disfigured patients. We plan to carry out allograft composite tissue transplantation after a
      careful systemic preparation.
    

Detailed description: 
      Severe facial deformities caused by burn, trauma, or tumor resection, are usually organs
      defects, such as ear, nose, eyelid, or lips and tissue defects involving the skin, fat
      tissue, muscle, cartilage, or bone etc. The optimal reconstruction of these specialized units
      is difficult to achieve.1 The face is not simply a mask but a functional, dynamic and
      important aesthetic organ. The functions of face include talking, smiling, eating, and
      winking. The reconstructive challenge is complicated by the fact that the human eye looks for
      and can detect the slightest abnormality in another's face. Traditional reconstructive
      procedures include free skin graft, application of local flaps, tissue prefabrication, tissue
      expansion, and free tissue transfer. Despite the application of meticulous techniques and
      artistic creativity, even the most skillful surgeon cannot reproduce this most complex part
      of the body. Facial reconstruction is still a tough challenge to surgeons.

      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..
    

Intervention name(s): human transplantation
Intervention type(s): Procedure
Intervention description(s): Allograft composite tissue transplantation. procedure. medication
Other intervention name(s): face allograft
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: face transplantation