Face InjuriesNCT04057638
Craniomaxillofacial and Upper Extremity Allotransplantation
A study testing Combined Craniomaxillofacial and Upper Extremity Allotransplantation in people with Face Injuries and Hand Injuries, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to evaluate functional and aesthetic outcomes of combined facial and upper extremity composite tissue allografts on patients who have not achieved functional and aesthetic outcomes with conventional reconstructive surgical strategies and prosthetic devices. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Face Injuries, Hand Injuries, Craniofacial Injuries
- What is being tested?
- Combined Craniomaxillofacial and Upper Extremity Allotransplantation
- 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
- 17 Jun 2019to 1 Jan 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Signed and dated all required Institutional Review Board (IRB) approved consent forms.
- Male or female recipient between the ages of 18-64 years. Recipients do not need to be of the same sex as the donor.
- Facial composite tissue defect requiring facial transplantation as determined by the treating Plastic and Reconstructive Surgeon. Inclusive facial functional subunit tissue loss. Including but not limited to irreparable peri-oral, peri-orbital, and peri-nasal damage.
- Missing part of one or both hands and forearms.
- Must be HIV negative at the time of transplant.
- Crossmatch is negative at the time of transplant.
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- Patient has been encouraged to seek a second opinion from a Plastic Surgeon with specialized focus in facial reconstruction.
- Patient has been encouraged to seek a second opinion from a Plastic Surgeon with specialized focus in upper extremity reconstruction.
- Willingness to participate in ongoing psychiatric, psychological and social work evaluations prior to and post-transplant surgery.
- The subject is able to complete pre-transplant examination and screening procedures.
- Patient has been approved by Patient Selection Committee for placement on the recipient waiting list.
- The subject is willing to continue immunosuppression regimen as directed by treating physician.
- Subject is willing and able to return to follow-up visits as described in treatment plan.
- Subjects must have autogenous tissue options available for reconstruction in event of graft failure.
- Normal glomerular filtration rate (GFR) >60.
- Negative pregnancy test within 48hrs of transplant for women of childbearing age and who agree to use a reliable form of contraception for one year following transplant.
Who cannot join
- Uncontrolled infection or severe concomitant diseases which would exclude the recipient from transplantation
- Serious co-morbidities
- Positive serology for HIV; Hepatitis B Antigen
- Active malignancy within 5 years with the exclusion of non-melanoma
- Substance abuse disorders not currently under control (as determined by the Michigan Alcohol Screening Test - see Appendix N.1: Subjects with a score of 3 or more will be excluded)
- Body Dysmorphic disorder (see Appendix N.2 for screening tool). Less severe psychiatric conditions are addressed on a case by case basis
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- Active Severe Psychiatric Illness
- Cognitive limitations affecting the patient's ability to provide informed consent
- Recent history of medical non-adherence
- Unstable social situation as evidence by lack of stable housing and/or lack of a supportive significant other.
- Recent history of medical non-adherence.
- Lack of stable housing and/or supportive significant other/caregiver throughout all phases of the study
- Currently active smoker within 1 year
- Subjects with any cognitive deficits related to a traumatic brain injury (TBI) and or any organic neurological disorders
- Any other psychological status that would hinder the success or safety of the transplantation.
- Level of amputation proximal to mid-humerus: some presence of proximal muscles is required to motor a functioning hand.
- Congenital Abnormalities: co-existent absence/atrophy/agenesis of any tissue may affect post-transplant results
- History of amputation of less than six months: subject must be allowed to attempt prosthetic use prior to hand transplantation. This can be waived in cases where the recipient requires amputation/revision of the transplant site at the time of transplantation. However, if at all possible, it is highly encouraged that the patient has ruled out prosthetics as an alternative to transplantation.
- Blindness: blind amputees may be poor candidates because sensory return in the hand may not provide sufficient protective sensation
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10017
Elie Ramly, MD, 929-455-5824, Elie.Ramly@nyulangone.org
Thomas Calahan, BA, 9294555826, Thomas.Calahan@nyulangone.org
About this study
Official title: Combined Craniomaxillofacial and Upper Extremity Allotransplantation
The purpose of this study is to evaluate functional and aesthetic outcomes of combined facial and upper extremity composite tissue allografts on patients who have not achieved functional and aesthetic outcomes with conventional reconstructive surgical strategies and prosthetic devices.
Read the detailed description
The purpose of this study is to see if an investigational surgery that transfers tissue from a non-living donor to a living individual will help restore greater function, appearance, and sensation to the face and upper extremity areas of individuals who have suffered injury to those areas. Upper extremity constitutes the part of the body including arm, forearm and hand. This procedure is called combined craniomaxillofacial and upper extremity allotransplantation or "combined face and upper extremity transplant".
This study will also collect data on how patients do during and after having a combined face and upper extremity transplant from a nonliving donor. Recovery and outcomes will be observed through clinical exams, x-rays, blood and tissue tests, and other associated evaluations at all follow up visits.
Participants are invited to take part in this research study who have suffered severe injury to the face and upper extremity and previous surgeries to repair the injury have not restored function, appearance, and sensation. Participants must have attempted a trial of prosthetics (artificial upper extremity), if at all possible.
- Conditions
- Face Injuries, Hand Injuries, Craniofacial Injuries, Upper Extremity Injuries, Facial Injuries, Facial Deformity
- Being tested
- Combined Craniomaxillofacial and Upper Extremity Allotransplantation
- Keywords
- Transplants, Transplantation, Craniomaxillofacial Transplantation, Upper Extremity Transplantation, Vascularized Composite Allotransplantation (VCA)
- Medical subject headings
- Facial Injuries, Hand Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Craniomaxillofacial and Upper Extremity AllotransplantationProcedure or surgery
Combined Craniomaxillofacial and Upper Extremity Allotransplantation
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | There will only be the treatment group in this study, which undergoes microvascular VCA transplantation. There will be no randomization, placebo or control groups. Receives: Procedure: Combined Craniomaxillofacial and Upper Extremity Allotransplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in function of the transplanted facial segment
This will be measured using electromyogram (EMG)
Measured: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in function of the transplanted facial segment
This will be measured using nerve conduction studies (NCS)
Measured: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in function of the transplanted facial segment
This will be measured using computerized tomography angiogram (CTA)
Measured: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in function of the transplanted facial segment
This will be measured using magnetic resonance imaging (MRI)
Measured: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in function of the transplanted facial segment
This will be measured using vision exams
Measured: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in function of the upper extremity transplant
This will be measured using pathology samples to check for rejection
Measured: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in function of the upper extremity transplant
This will be measured using electromyogram (EMG)
Measured: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in function of the upper extremity transplant
This will be measured using nerve conduction studies (NCS)
Measured: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in function of the upper extremity transplant
This will be measured using computerized tomography angiogram (CTA)
Measured: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in function of the upper extremity transplant
This will be measured using magnetic resonance imaging (MRI)
Measured: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in appearance of the transplanted facial segment
This will be measured using photography
Measured: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Change in appearance of the upper extremity transplant
This will be measured using photography
Measured: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2019
- Study start17 Jun 2019
- Primary completion1 Jan 2032 (estimated)
- Study completion1 Jan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Face InjuriesStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Model description
- This is a prospective longitudinal observational analysis of functional and aesthetic outcomes after treatment of severe facial defects and upper extremity injuries with microvascular composite tissue allotransplantation. There will only be the treatment group in this study, which undergoes microvascular VCA transplantation. There will be no randomization, placebo or control groups.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Rodriguez, MD, DDS, Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04057638
- Sponsor's protocol ID
- s19-00621
- Status last verified
- Oct 2026
- First submitted
- 6 Aug 2019
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Craniomaxillofacial and Upper Extremity Allotransplantation
- ClinicalTrials.gov ID
- NCT04057638
- Acronym / sponsor ID
- s19-00621
- Conditions
- Face Injuries, Hand Injuries, Craniofacial Injuries, Upper Extremity Injuries, Facial Injuries, Facial Deformity
- Keywords
- Transplants, Transplantation, Craniomaxillofacial Transplantation, Upper Extremity Transplantation, Vascularized Composite Allotransplantation (VCA)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 1 Jan 2032 (estimated)
- Study completion
- 1 Jan 2032 (estimated)
- First posted
- 15 Aug 2019 (actual)
- 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.
The purpose of this study is to evaluate functional and aesthetic outcomes of combined facial and upper extremity composite tissue allografts on patients who have not achieved functional and aesthetic outcomes with conventional reconstructive surgical strategies and prosthetic devices.
Detailed description
The purpose of this study is to see if an investigational surgery that transfers tissue from a non-living donor to a living individual will help restore greater function, appearance, and sensation to the face and upper extremity areas of individuals who have suffered injury to those areas. Upper extremity constitutes the part of the body including arm, forearm and hand. This procedure is called combined craniomaxillofacial and upper extremity allotransplantation or "combined face and upper extremity transplant".
This study will also collect data on how patients do during and after having a combined face and upper extremity transplant from a nonliving donor. Recovery and outcomes will be observed through clinical exams, x-rays, blood and tissue tests, and other associated evaluations at all follow up visits.
Participants are invited to take part in this research study who have suffered severe injury to the face and upper extremity and previous surgeries to repair the injury have not restored function, appearance, and sensation. Participants must have attempted a trial of prosthetics (artificial upper extremity), if at all possible.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective longitudinal observational analysis of functional and aesthetic outcomes after treatment of severe facial defects and upper extremity injuries with microvascular composite tissue allotransplantation. There will only be the treatment group in this study, which undergoes microvascular VCA transplantation. There will be no randomization, placebo or control groups.
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Procedure: Combined Craniomaxillofacial and Upper Extremity AllotransplantationThere will only be the treatment group in this study, which undergoes microvascular VCA transplantation. There will be no randomization, placebo or control groups. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Signed and dated all required Institutional Review Board (IRB) approved consent forms.
- Male or female recipient between the ages of 18-64 years. Recipients do not need to be of the same sex as the donor.
- Facial composite tissue defect requiring facial transplantation as determined by the treating Plastic and Reconstructive Surgeon. Inclusive facial functional subunit tissue loss. Including but not limited to irreparable peri-oral, peri-orbital, and peri-nasal damage.
- Missing part of one or both hands and forearms.
- Must be HIV negative at the time of transplant.
Key exclusion criteria (20 listed)
- Uncontrolled infection or severe concomitant diseases which would exclude the recipient from transplantation
- Serious co-morbidities
- Positive serology for HIV; Hepatitis B Antigen
- Active malignancy within 5 years with the exclusion of non-melanoma
- Substance abuse disorders not currently under control (as determined by the Michigan Alcohol Screening Test - see Appendix N.1: Subjects with a score of 3 or more will be excluded)
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 |
|---|---|---|
| Combined Craniomaxillofacial and Upper Extremity AllotransplantationCombined Craniomaxillofacial and Upper Extremity Allotransplantation | Procedure or surgery | Treatment group |
Primary outcome
Change in function of the transplanted facial segment
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using electromyogram (EMG)
Change in function of the transplanted facial segment
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using nerve conduction studies (NCS)
Change in function of the transplanted facial segment
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using computerized tomography angiogram (CTA)
Change in function of the transplanted facial segment
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using magnetic resonance imaging (MRI)
Change in function of the transplanted facial segment
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using vision exams
Change in function of the upper extremity transplant
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using pathology samples to check for rejection
Change in function of the upper extremity transplant
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using electromyogram (EMG)
Change in function of the upper extremity transplant
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using nerve conduction studies (NCS)
Change in function of the upper extremity transplant
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using computerized tomography angiogram (CTA)
Change in function of the upper extremity transplant
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using magnetic resonance imaging (MRI)
Change in appearance of the transplanted facial segment
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using photography
Change in appearance of the upper extremity transplant
Time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5
This will be measured using photography
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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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.
Eduardo Rodriguez, MD, DDS principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Craniomaxillofacial and Upper Extremity Allotransplantation in people with Face Injuries and Hand Injuries, run by NYU Langone Health 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 16 inclusion and 20 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: looking for participants now, as of the sponsor's last update on 30 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Calahan, BA ((929) 455-5826, Thomas.Calahan@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in function of the transplanted facial segment (time frame: Monthly for 6 months, every 6 months for 2 years, then annually up to year 5). The study lists 12 primary outcomes in all. 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 Oct 2026.