Craniomaxillofacial and Upper Extremity Allotransplantation

NCT04057638 | Recruiting DMC

• 1 other identifier: s19-00621
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

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)

Outcome Measures

Primary Outcomes (12)

• Change in function of the transplanted facial segment

  This will be measured using electromyogram (EMG)

  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)

  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)

  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)

  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

  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

  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)

  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)

  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)

  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)

  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

  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

  Monthly for 6 months, every 6 months for 2 years, then annually up to year 5

Study Arms (1)

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.

Procedure: Combined Craniomaxillofacial and Upper Extremity Allotransplantation

Interventions

Combined Craniomaxillofacial and Upper Extremity Allotransplantation PROCEDURE

Combined Craniomaxillofacial and Upper Extremity Allotransplantation

Treatment group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• Uncontrolled infection or severe concomitant diseases which would exclude the recipient from transplantation
• Serious co-morbidities
• Positive serology for HIV; Hepatitis B Antigen
• 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
• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10017, United States

RECRUITING

MeSH Terms

Conditions

Facial Injuries; Hand Injuries

Condition Hierarchy (Ancestors)

Craniocerebral Trauma; Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries

Study Officials

• Eduardo Rodriguez, MD, DDS

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Calahan, BA

CONTACT

(929) 455-5826; Thomas.Calahan@nyulangone.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 15, 2019
• Study Start: June 17, 2019
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Locations

US (1)