Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00663988 |
| Other study ID # |
XJ-GuoSZ0709 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 3
|
| First received |
April 20, 2008 |
| Last updated |
April 20, 2008 |
| Start date |
April 2006 |
Study information
| Verified date |
February 2006 |
| Source |
Xijing Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
China: Food and Drug Administration |
| Study type |
Interventional
|
Clinical Trial 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.
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..
