Pharmaceutical PreparationsPhase 3NCT00663988
Human Partial Facial Allotransplantation
A Phase 3 study testing human transplantation in people with Pharmaceutical Preparations, run by Xijing Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men only
- Conditions the study is for
- Pharmaceutical Preparations
- What is being tested?
- human transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteChina
- Study dates
- Apr 2006to Apr 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- normal function of heart/liver/kidney
- donor: same boold type
- at least 3 sites were matched within 6 HLA sites
Who cannot join
- abnormal function of heart/liver/kidney
- donor: not the same boold type and 1 or 2 sites were matched within 6 HLA sites
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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..
- Conditions
- Pharmaceutical Preparations
- Being tested
- human transplantation
- Keywords
- face transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human transplantationProcedure or surgery
Also called face allograft
Allograft composite tissue transplantation. procedure. medication
| Study group | Role | What they receive |
|---|---|---|
| III | Experimental | The effect of human partial facial allotransplantation Receives: Procedure: human transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
improved health
Measured: 1 M
Secondary outcomes (1)
improvement of abnormal states
Measured: 3 Y
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2008 (estimated)
- Study startApr 2006
- Primary completionApr 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pharmaceutical PreparationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Shuzhong Guo, Dr, Study director, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00663988
- Sponsor's protocol ID
- XJ-GuoSZ0709
- Status last verified
- Feb 2006
- First submitted
- 20 Apr 2008
- Last updated
- 22 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 18077810Xudong 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.
PubMed 16721082
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Partial Facial Allotransplantation
- ClinicalTrials.gov ID
- NCT00663988
- Acronym / sponsor ID
- XJ-GuoSZ0709
- Conditions
- Pharmaceutical Preparations
- Keywords
- face transplantation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- Apr 2006
- Primary completion
- Apr 2006 (actual)
- First posted
- 22 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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..
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| III | Experimental | Procedure: human transplantationThe effect of human partial facial allotransplantation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- normal function of heart/liver/kidney
Key exclusion criteria (2 listed)
- abnormal function of heart/liver/kidney
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human transplantationAlso: face allograftAllograft composite tissue transplantation. procedure. medication | Procedure or surgery | III |
Primary outcome
improved health
Time frame: 1 M
1 secondary outcome
improvement of abnormal states
Time frame: 3 Y
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2008.
- Background: PubMed 18077810Dubernard 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.
- Results publication: PubMed 16721082Xudong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shuzhong Guo, Dr study director
Xijing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing human transplantation in people with Pharmaceutical Preparations, run by Xijing Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improved health (time frame: 1 M). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00663988, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2008.