Severe Facial DeformityNCT01281267
Face Transplantation for Treatment of Severe Facial Deformity
A study testing Facial Allograft Transplantation in people with Severe Facial Deformity, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Face transplantation surgery is the transfer of face tissue from a deceased human donor to a patient with a severe facial deformity. Face transplantation is an innovative reconstructive procedure that has the potential to significantly improve the lives of patients with severe facial injuries. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Severe Facial Deformity
- What is being tested?
- Facial Allograft Transplantation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2009to 12 Nov 2019
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years.
- Loss of a major part of the face, such as the nose or the lips, or at least 25% of the facial tissue.
- The facial defect cannot be restored with traditional reconstruction techniques.
- Signed written informed consent.
- Willing to complete psychological and social evaluations.
- Willing to take immunosuppressants - drugs that help prevent rejection of the transplant - for life.
- Willing to return for follow-up visits as determined by the treating physician and to comply with extensive post-transplant rehabilitation therapy.
- Willing to receive standard vaccinations prior to the transplant, such as influenza and hepatitis B.
Who cannot join
- Active malignancy.
- High risk of return of malignancy.
- History of persistent non-compliance.
- Findings of psychological evaluation that indicate inability to comply with physician's orders or mental instability.
- Any diagnosis that puts the subject at risk during the face transplant surgery.
- Absence of adequate donor sites for skin grafting in the event of transplant failure.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham & Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Transplantation of Allograft Face or Facial Subunit for Treatment of Severe Facial Deformation
Face transplantation surgery is the transfer of face tissue from a deceased human donor to a patient with a severe facial deformity. Face transplantation is an innovative reconstructive procedure that has the potential to significantly improve the lives of patients with severe facial injuries. The purpose of this study is to develop the best practices for facial transplantation that will improve the outcomes of future face transplant recipients.
Read the detailed description
The United States Department of Defense (DoD) awarded Brigham and Women's Hospital (BWH) a research contract to fund 5 face transplantation surgeries.
The investigators are now actively seeking candidates for the procedure. The primary requirements to be considered as a candidate for face transplant surgery are: at least 18 years old; lost a major part of the face, such as the nose or the lips, or lost at least 25% of their facial tissue; and the facial injury cannot be treated acceptably by conventional reconstructive surgery. There are number of other factors that the investigators consider to determine who would be a suitable candidate.
From the time the investigators begin our search for a qualified face transplant recipient to the continuing care the investigators provide following surgery, a significant amount of time, expertise, and attentiveness is contributed toward making the procedure a progressive success. Below is an overview of what happens before, during and after a face transplant procedure.
Face transplant candidates go through an extensive screening process that is likely to last several months. This screening includes a psychiatric and social support evaluation and a series of imaging tests to help determine a patient's physical and mental readiness for the procedure. If, upon completion of the screening process, it is determined that a patient is a suitable candidate, the investigators will place the patient on a transplant waiting list. The investigators will then begin working to find a donor who matches the recipient's tissue requirements - e.g., similar age, right blood type. This search could take many months, and, if a suitable donor is not found within one year, the investigators will speak with the patient to determine whether they're willing to continue waiting. When a donor is found, the investigators will immediately inform the patient about when to arrive at the hospital for the operation. As the timing for this type of procedure is extremely important, patients are expected to be readily available.
The area most likely to be reconstructed in a face transplant is the central region of the face, which includes the nose and lips, as these facial structures are the most difficult to reconstruct with conventional plastic surgery techniques. In our most recent case, the face transplant included the entire nose; the soft tissues of the mid-face, including all its blood vessels, muscles, and nerves; and a significant portion of the mid-facial skeleton. Surgeons will then connect the facial graft blood vessels to the patient's blood vessels under a microscope to restore blood circulation before connecting nerves and other tissue, such as bone, cartilage and muscles, as needed.
While the face transplant is taking place, a separate, smaller surgery will also be performed. The investigators will take a skin sample (graft) from the arm of the donor and then attach the sample to the patient's chest or abdomen. The intent is to have the graft behave like the face transplant tissue, eventually becoming part of the patient's own skin. This is done so that later the investigators can take tiny samples (biopsies) of the new chest/abdomen tissue to look for signs of rejection, thereby minimizing the need to disturb the new face tissue after surgery.
Immediately after surgery, the face transplant recipient will be taken to the Intensive Care Unit (ICU) for observation. The patient will typically stay in the ICU for one or two days and then be moved to a private room. At this point, a physical therapist will help the patient regain as much facial movement as possible, and a psychiatrist will discuss any psychological concerns.
The patient will stay in the hospital until both the plastic surgery and medical transplant teams agree that it is safe for the patient to return home. This post-operative stay is anticipated to be approximately 7-14 days, but can vary due to a number of factors.
Following their discharge, face transplant patients will need to return to BWH for routine visits. These visits will include monitoring transplant drug levels (immune suppressants) through regular blood tests, imaging tests, assessing quality of life and checking for the return of sensation and movement to the face. The investigators will also periodically examine small tissue samples from the chest/abdomen graft under a microscope to look for any signs of rejection. These visits will typically take place on a weekly basis for the first three months and then at least once a month for the first year following surgery.
After the first year, it is expected that face transplant patients will need to visit the hospital less and less as time passes. However, patients should be prepared to make a lifetime commitment to immune suppressants to help prevent the rejection of the transplanted face tissue.
- Conditions
- Severe Facial Deformity
- Being tested
- Facial Allograft Transplantation
- Keywords
- facial transplantation, face transplantation, composite tissue allotransplantation, VCA, composite tissue allograft, facial allograft
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial Allograft TransplantationProcedure or surgery
Also called face transplantation, facial transplantation, composite facial allograft transplantation
Facial allograft transplantation surgery is the transfer of face tissue from a deceased human donor to a patient with a severe facial deformity.
| Study group | Role | What they receive |
|---|---|---|
| Face transplantation | Experimental | Not described Receives: Procedure: Facial Allograft Transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcomes of face transplantation.
We will undertake an objective evaluation of the results of face transplantation in an 'outcome-oriented study'.
Measured: Subjects will be followed for 18 months after face transplantation
Secondary outcomes (5)
Efficacy and optimization of the immune suppression protocol.
We will evaluate the risks of rejection or likelihood of tolerance induction by measuring specific parameters in the blood or tissue, including: Serum alloantibodies concentration, numbers/phenotype of specific T cell alloreactivity in the peripheral blood, phenotypic characterization of graft infiltrating cells and local gene expression of cells and cytokines.
Measured: 18 months
Procedural outcomes of face transplantation
We will optimize the screening, pre-operative, peri-operative and follow-up procedures of face transplantation.
Measured: From subject recruitment to 18 months after transplantation
Functional outcomes of face transplantation
We will evaluate the return of facial sensory and motor function after face transplantation.
Measured: Subjects will be followed for 18 months following face transplantation
Psychosocial outcomes of face transplantation
We will evaluate the psychological and social outcomes of face transplantation by evaluating the subject's quality of life at various time points before and after transplantation.
Measured: Subjects will be followed up for 18 months following face transplantation
Financial and economic aspects of face transplantation
We will evaluate the cost-effectiveness of face transplantation.
Measured: Subjects will be followed for 18 months after face transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2011 (estimated)
- Study start1 Sep 2009
- Primary completion31 Oct 2019
- Study completion12 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Severe Facial DeformityStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Bodhan Pomahac, Brigham and Women's Hospital
- Investigators
- Bohdan Pomahac, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01281267
- Sponsor's protocol ID
- 2008P000550
- Other IDs
- W911QY09C0216
- Status last verified
- Jan 2021
- First submitted
- 20 Jan 2011
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Pomahac B, Aflaki P. Composite tissue transplantation: a new era in transplantation surgery. Eplasty. 2010 Sep 15;10:e58.
PubMed 20862294Aflaki P, Nelson C, Balas B, Pomahac B. Simulated central face transplantation: age consideration in matching donors and recipients. J Plast Reconstr Aesthet Surg. 2010 Mar;63(3):e283-5. doi: 10.1016/j.bjps.2009.08.013. Epub 2009 Sep 13. No abstract available.
PubMed 19748842Pomahac B, Aflaki P, Nelson C, Balas B. Evaluation of appearance transfer and persistence in central face transplantation: a computer simulation analysis. J Plast Reconstr Aesthet Surg. 2010 May;63(5):733-8. doi: 10.1016/j.bjps.2009.01.078. Epub 2009 Apr 23.
PubMed 19398394Kiwanuka H, Bueno EM, Diaz-Siso JR, Sisk GC, Lehmann LS, Pomahac B. Evolution of ethical debate on face transplantation. Plast Reconstr Surg. 2013 Dec;132(6):1558-1568. doi: 10.1097/PRS.0b013e3182a97e2b.
PubMed 24281583Lamparello BM, Bueno EM, Diaz-Siso JR, Sisk GC, Pomahac B. Face time: educating face transplant candidates. Eplasty. 2013 Jul 4;13:e36. Print 2013.
PubMed 23861990Soga S, Ersoy H, Mitsouras D, Schultz K, Whitmore AG, Powers SL, Steigner ML, Signorelli J, Prior RF, Rybicki FJ, Pomahac B. Surgical planning for composite tissue allotransplantation of the face using 320-detector row computed tomography. J Comput Assist Tomogr. 2010 Sep-Oct;34(5):766-9. doi: 10.1097/RCT.0b013e3181e9c133.
PubMed 20861783Pomahac B, Pribaz J, Eriksson E, Annino D, Caterson S, Sampson C, Chun Y, Orgill D, Nowinski D, Tullius SG. Restoration of facial form and function after severe disfigurement from burn injury by a composite facial allograft. Am J Transplant. 2011 Feb;11(2):386-93. doi: 10.1111/j.1600-6143.2010.03368.x. Epub 2011 Jan 7.
PubMed 21214855Edrich T, Pomahac B, Lu JT, Couper GS, Gerner P. Perioperative management of partial face transplantation involving a heparin antibody-positive donor. J Clin Anesth. 2011 Jun;23(4):318-21. doi: 10.1016/j.jclinane.2010.07.004.
PubMed 21663819Pomahac B, Nowinski D, Diaz-Siso JR, Bueno EM, Talbot SG, Sinha I, Westvik TS, Vyas R, Singhal D. Face transplantation. Curr Probl Surg. 2011 May;48(5):293-357. doi: 10.1067/j.cpsurg.2011.01.003. No abstract available.
PubMed 21463717Pomahac B, Lengele B, Ridgway EB, Matros E, Andrews BT, Cooper JS, Kutz R, Pribaz JJ. Vascular considerations in composite midfacial allotransplantation. Plast Reconstr Surg. 2010 Feb;125(2):517-522. doi: 10.1097/PRS.0b013e3181c82e6f.
PubMed 19910848Saavedra AP, Bueno EM, Granter SR, Pomahac B. Transmission of donor-specific skin condition from donor to recipient of facial allograft. Am J Transplant. 2011 Jun;11(6):1340. doi: 10.1111/j.1600-6143.2011.03596.x. No abstract available.
PubMed 21645261Kumamaru KK, Sisk GC, Mitsouras D, Schultz K, Steigner ML, George E, Enterline DS, Bueno EM, Pomahac B, Rybicki FJ. Vascular communications between donor and recipient tissues after successful full face transplantation. Am J Transplant. 2014 Mar;14(3):711-9. doi: 10.1111/ajt.12608. Epub 2014 Feb 6.
PubMed 24502329Lian CG, Bueno EM, Granter SR, Laga AC, Saavedra AP, Lin WM, Susa JS, Zhan Q, Chandraker AK, Tullius SG, Pomahac B, Murphy GF. Biomarker evaluation of face transplant rejection: association of donor T cells with target cell injury. Mod Pathol. 2014 Jun;27(6):788-99. doi: 10.1038/modpathol.2013.249. Epub 2014 Jan 17.
PubMed 24434898Sinha I, Pomahac B. Split rejection in vascularized composite allotransplantation. Eplasty. 2013 Oct 8;13:e53.
PubMed 24244785Schultz K, George E, Mullen KM, Steigner ML, Mitsouras D, Bueno EM, Pomahac B, Rybicki FJ, Kumamaru KK. Reduced radiation exposure for face transplant surgical planning computed tomography angiography. PLoS One. 2013 Apr 26;8(4):e63079. doi: 10.1371/journal.pone.0063079. Print 2013.
PubMed 23638180
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transplantation of Allograft Face or Facial Subunit for Treatment of Severe Facial Deformation
- ClinicalTrials.gov ID
- NCT01281267
- Acronym / sponsor ID
- 2008P000550
- Conditions
- Severe Facial Deformity
- Keywords
- facial transplantation, face transplantation, composite tissue allotransplantation, VCA, composite tissue allograft, facial allograft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 1 Sep 2009 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 12 Nov 2019 (actual)
- First posted
- 21 Jan 2011 (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.
Face transplantation surgery is the transfer of face tissue from a deceased human donor to a patient with a severe facial deformity. Face transplantation is an innovative reconstructive procedure that has the potential to significantly improve the lives of patients with severe facial injuries. The purpose of this study is to develop the best practices for facial transplantation that will improve the outcomes of future face transplant recipients.
Detailed description
The United States Department of Defense (DoD) awarded Brigham and Women's Hospital (BWH) a research contract to fund 5 face transplantation surgeries.
The investigators are now actively seeking candidates for the procedure. The primary requirements to be considered as a candidate for face transplant surgery are: at least 18 years old; lost a major part of the face, such as the nose or the lips, or lost at least 25% of their facial tissue; and the facial injury cannot be treated acceptably by conventional reconstructive surgery. There are number of other factors that the investigators consider to determine who would be a suitable candidate.
From the time the investigators begin our search for a qualified face transplant recipient to the continuing care the investigators provide following surgery, a significant amount of time, expertise, and attentiveness is contributed toward making the procedure a progressive success. Below is an overview of what happens before, during and after a face transplant procedure.
Face transplant candidates go through an extensive screening process that is likely to last several months. This screening includes a psychiatric and social support evaluation and a series of imaging tests to help determine a patient's physical and mental readiness for the procedure. If, upon completion of the screening process, it is determined that a patient is a suitable candidate, the investigators will place the patient on a transplant waiting list. The investigators will then begin working to find a donor who matches the recipient's tissue requirements - e.g., similar age, right blood type. This search could take many months, and, if a suitable donor is not found within one year, the investigators will speak with the patient to determine whether they're willing to continue waiting. When a donor is found, the investigators will immediately inform the patient about when to arrive at the hospital for the operation. As the timing for this type of procedure is extremely important, patients are expected to be readily available.
The area most likely to be reconstructed in a face transplant is the central region of the face, which includes the nose and lips, as these facial structures are the most difficult to reconstruct with conventional plastic surgery techniques. In our most recent case, the face transplant included the entire nose; the soft tissues of the mid-face, including all its blood vessels, muscles, and nerves; and a significant portion of the mid-facial skeleton. Surgeons will then connect the facial graft blood vessels to the patient's blood vessels under a microscope to restore blood circulation before connecting nerves and other tissue, such as bone, cartilage and muscles, as needed.
While the face transplant is taking place, a separate, smaller surgery will also be performed. The investigators will take a skin sample (graft) from the arm of the donor and then attach the sample to the patient's chest or abdomen. The intent is to have the graft behave like the face transplant tissue, eventually becoming part of the patient's own skin. This is done so that later the investigators can take tiny samples (biopsies) of the new chest/abdomen tissue to look for signs of rejection, thereby minimizing the need to disturb the new face tissue after surgery.
Immediately after surgery, the face transplant recipient will be taken to the Intensive Care Unit (ICU) for observation. The patient will typically stay in the ICU for one or two days and then be moved to a private room. At this point, a physical therapist will help the patient regain as much facial movement as possible, and a psychiatrist will discuss any psychological concerns.
The patient will stay in the hospital until both the plastic surgery and medical transplant teams agree that it is safe for the patient to return home. This post-operative stay is anticipated to be approximately 7-14 days, but can vary due to a number of factors.
Following their discharge, face transplant patients will need to return to BWH for routine visits. These visits will include monitoring transplant drug levels (immune suppressants) through regular blood tests, imaging tests, assessing quality of life and checking for the return of sensation and movement to the face. The investigators will also periodically examine small tissue samples from the chest/abdomen graft under a microscope to look for any signs of rejection. These visits will typically take place on a weekly basis for the first three months and then at least once a month for the first year following surgery.
After the first year, it is expected that face transplant patients will need to visit the hospital less and less as time passes. However, patients should be prepared to make a lifetime commitment to immune suppressants to help prevent the rejection of the transplanted face tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Face transplantation | Experimental | Procedure: Facial Allograft Transplantation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age between 18 and 60 years.
- Loss of a major part of the face, such as the nose or the lips, or at least 25% of the facial tissue.
- The facial defect cannot be restored with traditional reconstruction techniques.
- Signed written informed consent.
- Willing to complete psychological and social evaluations.
Key exclusion criteria (6 listed)
- Active malignancy.
- High risk of return of malignancy.
- History of persistent non-compliance.
- Findings of psychological evaluation that indicate inability to comply with physician's orders or mental instability.
- Any diagnosis that puts the subject at risk during the face transplant surgery.
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 |
|---|---|---|
| Facial Allograft TransplantationAlso: face transplantation, facial transplantation, composite facial allograft transplantationFacial allograft transplantation surgery is the transfer of face tissue from a deceased human donor to a patient with a severe facial deformity. | Procedure or surgery | Face transplantation |
Primary outcome
Outcomes of face transplantation.
Time frame: Subjects will be followed for 18 months after face transplantation
We will undertake an objective evaluation of the results of face transplantation in an 'outcome-oriented study'.
5 secondary outcomes
Efficacy and optimization of the immune suppression protocol.
Time frame: 18 months
Procedural outcomes of face transplantation
Time frame: From subject recruitment to 18 months after transplantation
Functional outcomes of face transplantation
Time frame: Subjects will be followed for 18 months following face transplantation
Psychosocial outcomes of face transplantation
Time frame: Subjects will be followed up for 18 months following face transplantation
Financial and economic aspects of face transplantation
Time frame: Subjects will be followed for 18 months after face transplantation
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 27 Jan 2021.
- Background: PubMed 20862294Pomahac B, Aflaki P. Composite tissue transplantation: a new era in transplantation surgery. Eplasty. 2010 Sep 15;10:e58.
- Background: PubMed 19748842Aflaki P, Nelson C, Balas B, Pomahac B. Simulated central face transplantation: age consideration in matching donors and recipients. J Plast Reconstr Aesthet Surg. 2010 Mar;63(3):e283-5. doi: 10.1016/j.bjps.2009.08.013. Epub 2009 Sep 13. No abstract available.
- Background: PubMed 19398394Pomahac B, Aflaki P, Nelson C, Balas B. Evaluation of appearance transfer and persistence in central face transplantation: a computer simulation analysis. J Plast Reconstr Aesthet Surg. 2010 May;63(5):733-8. doi: 10.1016/j.bjps.2009.01.078. Epub 2009 Apr 23.
- Background: PubMed 24281583Kiwanuka H, Bueno EM, Diaz-Siso JR, Sisk GC, Lehmann LS, Pomahac B. Evolution of ethical debate on face transplantation. Plast Reconstr Surg. 2013 Dec;132(6):1558-1568. doi: 10.1097/PRS.0b013e3182a97e2b.
- Background: PubMed 23861990Lamparello BM, Bueno EM, Diaz-Siso JR, Sisk GC, Pomahac B. Face time: educating face transplant candidates. Eplasty. 2013 Jul 4;13:e36. Print 2013.
- Results publication: PubMed 20861783Soga S, Ersoy H, Mitsouras D, Schultz K, Whitmore AG, Powers SL, Steigner ML, Signorelli J, Prior RF, Rybicki FJ, Pomahac B. Surgical planning for composite tissue allotransplantation of the face using 320-detector row computed tomography. J Comput Assist Tomogr. 2010 Sep-Oct;34(5):766-9. doi: 10.1097/RCT.0b013e3181e9c133.
- Results publication: PubMed 21214855Pomahac B, Pribaz J, Eriksson E, Annino D, Caterson S, Sampson C, Chun Y, Orgill D, Nowinski D, Tullius SG. Restoration of facial form and function after severe disfigurement from burn injury by a composite facial allograft. Am J Transplant. 2011 Feb;11(2):386-93. doi: 10.1111/j.1600-6143.2010.03368.x. Epub 2011 Jan 7.
- Results publication: PubMed 21663819Edrich T, Pomahac B, Lu JT, Couper GS, Gerner P. Perioperative management of partial face transplantation involving a heparin antibody-positive donor. J Clin Anesth. 2011 Jun;23(4):318-21. doi: 10.1016/j.jclinane.2010.07.004.
- Results publication: PubMed 21463717Pomahac B, Nowinski D, Diaz-Siso JR, Bueno EM, Talbot SG, Sinha I, Westvik TS, Vyas R, Singhal D. Face transplantation. Curr Probl Surg. 2011 May;48(5):293-357. doi: 10.1067/j.cpsurg.2011.01.003. No abstract available.
- Results publication: PubMed 19910848Pomahac B, Lengele B, Ridgway EB, Matros E, Andrews BT, Cooper JS, Kutz R, Pribaz JJ. Vascular considerations in composite midfacial allotransplantation. Plast Reconstr Surg. 2010 Feb;125(2):517-522. doi: 10.1097/PRS.0b013e3181c82e6f.
- Results publication: PubMed 21645261Saavedra AP, Bueno EM, Granter SR, Pomahac B. Transmission of donor-specific skin condition from donor to recipient of facial allograft. Am J Transplant. 2011 Jun;11(6):1340. doi: 10.1111/j.1600-6143.2011.03596.x. No abstract available.
- Results publication: PubMed 24502329Kumamaru KK, Sisk GC, Mitsouras D, Schultz K, Steigner ML, George E, Enterline DS, Bueno EM, Pomahac B, Rybicki FJ. Vascular communications between donor and recipient tissues after successful full face transplantation. Am J Transplant. 2014 Mar;14(3):711-9. doi: 10.1111/ajt.12608. Epub 2014 Feb 6.
- Study's official webpageLink provided by the sponsor.
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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.
Bohdan Pomahac, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial Allograft Transplantation in people with Severe Facial Deformity, run by Brigham and Women's Hospital at 1 site in United States.
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 8 inclusion and 6 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 27 Jan 2021. 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 United States. 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.
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?
Outcomes of face transplantation. (time frame: Subjects will be followed for 18 months after face transplantation). 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 NCT01281267, which also lists 20 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 27 Jan 2021.