Transplantation: Facial TransplantationNCT01140087
Face Transplantation
A study testing Face Transplant in people with Transplantation: Facial Transplantation, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This study aims to: 1. Perform face transplants on people who have suffered severe facial trauma with tissue and functional loss; and 2. Evaluate the acceptance and function of the transplanted tissue. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Transplantation: Facial Transplantation
- What is being tested?
- Face Transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to 14 Aug 2020
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 18-64 years of age
- Facial defect or injury requiring facial transplantation as determined by the treating Plastic and Reconstructive Surgeon
- Signed written informed consent
- Able to complete psychiatric evaluations
- Willing and able to continue immunosuppression regimen as directed by treating physician
- Willing and able to return for follow-up visits as described in the treatment plan
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- Must have autogenous tissue options available for reconstruction in event of graft failure
- Laboratory values as defined by research protocol
- Willing to undergo review by Participant Selection Committee and be placed on a transplant recipient waitlist
Who cannot join
- Pre-existing disease that would exclude the recipient from transplantation
- Active infection
- Ongoing substance abuse
- HIV positive
- Positive for Hepatitis B or C
- Active malignancy
- Pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21201
About this study
Official title: Maxillofacial Composite Tissue Allograft Transplantation: Face Transplant
This study aims to:
- Perform face transplants on people who have suffered severe facial trauma with tissue and functional loss; and
- Evaluate the acceptance and function of the transplanted tissue.
Read the detailed description
For patients with severe facial deformities or facial wounds from traumatic injuries, we would like to pursue the use of a face transplant to help reconstruct a person's damaged face. Our goal is to not only give the patient back a normal appearance to their face but also the functioning, movement, and sensation of their face including that of the lips, mouth, and eyes. For some patients with severe face deformities simple tasks such as smiling, talking, eating, kissing a loved one, or even just being able to contain their saliva become difficult, if not impossible. These patients often become depressed because of their facial deformities.
Although there are some techniques in plastic and reconstructive surgery that can repair the look of a patient's face, often these cannot replace the moving parts of the face. Currently, patients with severe facial deformities would undergo several reconstructive surgeries with their own tissues, called autologous transplant. This surgery often leaves unacceptable scars and deformities of the patient's donor sites. Also, this conventional reconstruction method requires many returns to the operating room to carefully form and shape the transplanted free flap. Lastly, this type of reconstruction is still limited, as it does not provide a reliable return in function, sensation, and appearance for the damaged parts of the face.
Instead, if we use a composite tissue allograft (CTA), or face transplant from a donor who is brain dead such as in heart, kidney and liver transplants, we could replace the damaged parts of the face with the same missing parts that could return movement as well. However, since the transplanted facial tissues are from another person, these face transplant recipients need medicines that would keep their body from rejecting the new tissues. This new course of medicines would be their daily responsibility. Though there are risks with taking these medicines, the risks have been lowered by many prior studies that have been done with patients who have had other organ transplants. However, the risks are still a consideration when deciding to choose this option for correcting severe facial deformities.
This study aims to perform a face transplant on a person who has suffered a severe facial trauma with tissue and functional loss, and with limited other established surgical options to repair their deformities. We will conduct the surgery and prospectively follow the patient to monitor his or her clinical and functional outcomes and ensure that optimal results are achieved. We will systematically document and record the entire process of the patient's surgery and recovery. An important factor of this surgery's success is that the patient strictly follows and takes the required course of medicines to prevent rejection of the donor tissues. In order to ensure that the tissue survives and is not rejected by the patient, we will continuously check various clinical values, such as blood work, tissue samples, and x-ray images.
We would like to offer facial segment transplantation as a reconstructive option to patients with severe facial deformities. We feel facial transplantation has now become a viable option for certain patients. If successful, this will contribute to future research and development in the field of tissue transplantation. Most importantly, our goal is to offer patients the best option in reconstruction to restore both form and function who otherwise do not have another option.
- Conditions
- Transplantation: Facial Transplantation
- Being tested
- Face Transplant
- Keywords
- Face Transplant, Composite Tissue Allograft, Facial Allotransplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face TransplantProcedure or surgery
Transplantation of donor facial skin, tissue, muscle, and bone as needed
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | Face Transplantation Receives: Procedure: Face Transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the success of the face transplant
We will measure the restoration of function, sensation, and appearance of the transplanted facial segment
Measured: Monthly for 6 months, every 6 months for 2 years, then annually
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2010 (estimated)
- Study startSep 2010
- Primary completion14 Aug 2020
- Study completion14 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplantation: Facial TransplantationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rolf Barth, University of Maryland, Baltimore
- Investigators
- Rolf Barth, MD, Principal investigator, U of Maryland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01140087
- Sponsor's protocol ID
- HP-00040219
- Other IDs
- N00014-07-1-0298
- Status last verified
- Sep 2021
- First submitted
- 7 Jun 2010
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maxillofacial Composite Tissue Allograft Transplantation: Face Transplant
- ClinicalTrials.gov ID
- NCT01140087
- Acronym / sponsor ID
- HP-00040219
- Conditions
- Transplantation: Facial Transplantation
- Keywords
- Face Transplant, Composite Tissue Allograft, Facial Allotransplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- 14 Aug 2020 (actual)
- Study completion
- 14 Aug 2020 (actual)
- First posted
- 9 Jun 2010 (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.
This study aims to:
- Perform face transplants on people who have suffered severe facial trauma with tissue and functional loss; and
- Evaluate the acceptance and function of the transplanted tissue.
Detailed description
For patients with severe facial deformities or facial wounds from traumatic injuries, we would like to pursue the use of a face transplant to help reconstruct a person's damaged face. Our goal is to not only give the patient back a normal appearance to their face but also the functioning, movement, and sensation of their face including that of the lips, mouth, and eyes. For some patients with severe face deformities simple tasks such as smiling, talking, eating, kissing a loved one, or even just being able to contain their saliva become difficult, if not impossible. These patients often become depressed because of their facial deformities.
Although there are some techniques in plastic and reconstructive surgery that can repair the look of a patient's face, often these cannot replace the moving parts of the face. Currently, patients with severe facial deformities would undergo several reconstructive surgeries with their own tissues, called autologous transplant. This surgery often leaves unacceptable scars and deformities of the patient's donor sites. Also, this conventional reconstruction method requires many returns to the operating room to carefully form and shape the transplanted free flap. Lastly, this type of reconstruction is still limited, as it does not provide a reliable return in function, sensation, and appearance for the damaged parts of the face.
Instead, if we use a composite tissue allograft (CTA), or face transplant from a donor who is brain dead such as in heart, kidney and liver transplants, we could replace the damaged parts of the face with the same missing parts that could return movement as well. However, since the transplanted facial tissues are from another person, these face transplant recipients need medicines that would keep their body from rejecting the new tissues. This new course of medicines would be their daily responsibility. Though there are risks with taking these medicines, the risks have been lowered by many prior studies that have been done with patients who have had other organ transplants. However, the risks are still a consideration when deciding to choose this option for correcting severe facial deformities.
This study aims to perform a face transplant on a person who has suffered a severe facial trauma with tissue and functional loss, and with limited other established surgical options to repair their deformities. We will conduct the surgery and prospectively follow the patient to monitor his or her clinical and functional outcomes and ensure that optimal results are achieved. We will systematically document and record the entire process of the patient's surgery and recovery. An important factor of this surgery's success is that the patient strictly follows and takes the required course of medicines to prevent rejection of the donor tissues. In order to ensure that the tissue survives and is not rejected by the patient, we will continuously check various clinical values, such as blood work, tissue samples, and x-ray images.
We would like to offer facial segment transplantation as a reconstructive option to patients with severe facial deformities. We feel facial transplantation has now become a viable option for certain patients. If successful, this will contribute to future research and development in the field of tissue transplantation. Most importantly, our goal is to offer patients the best option in reconstruction to restore both form and function who otherwise do not have another option.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Procedure: Face TransplantFace Transplantation |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 18-64 years of age
- Facial defect or injury requiring facial transplantation as determined by the treating Plastic and Reconstructive Surgeon
- Signed written informed consent
- Able to complete psychiatric evaluations
- Willing and able to continue immunosuppression regimen as directed by treating physician
Key exclusion criteria (7 listed)
- Pre-existing disease that would exclude the recipient from transplantation
- Active infection
- Ongoing substance abuse
- HIV positive
- Positive for Hepatitis B or C
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 |
|---|---|---|
| Face TransplantTransplantation of donor facial skin, tissue, muscle, and bone as needed | Procedure or surgery | Interventional |
Primary outcome
Evaluate the success of the face transplant
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually
We will measure the restoration of function, sensation, and appearance of the transplanted facial segment
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 30 Sep 2021.
Related trials for Transplantation: Facial Transplantation
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Facial Vascularized Composite Allotransplantation: A Study Evaluating Safety, Functional Outcomes, and Patient-Reported Psychosocial Outcomes
Facial Vascularized Composite Allotransplantation, Functional Recovery
RecruitingPhase 2
Human Craniomaxillofacial Allotransplantation
Facial Injuries, Traumatic Wounds and Injuries
Recruiting
Craniomaxillofacial and Upper Extremity Allotransplantation
Face Injuries, Hand Injuries
Enrolling by invitation
Effect of Platelet-Rich Plasma on Graft Uptake and Postoperative Outcomes in Full-Thickness Skin Grafting of Face and Neck
Skin Transplantation, Reconstructive Surgical Procedures
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.
Rolf Barth, MD principal investigator
U of Maryland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face Transplant in people with Transplantation: Facial Transplantation, run by University of Maryland, Baltimore 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 9 inclusion and 7 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 30 Sep 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?
Evaluate the success of the face transplant (time frame: Monthly for 6 months, every 6 months for 2 years, then annually). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2021.