RECRUITING

Craniomaxillofacial and Upper Extremity Allotransplantation

Conditions

Face Injuries Hand Injuries Craniofacial Injuries Upper Extremity Injuries Facial Injuries Facial Deformity Transplants Transplantation Craniomaxillofacial Transplantation Upper Extremity Transplantation Vascularized Composite Allotransplantation (VCA)

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Combined Craniomaxillofacial and Upper Extremity Allotransplantation

Quick Facts

Study Start:2019-06-17

Study Completion:2026-01-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04057638

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 64 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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. * 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.	* 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 * 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

Inclusion Criteria

Exclusion Criteria

* 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.
* 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.

* 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
* 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

Contacts and Locations

Study Contact

Thomas Calahan, BA

CONTACT

(929) 455-5826

Thomas.Calahan@nyulangone.org

Principal Investigator

Eduardo Rodriguez, MD, DDS

PRINCIPAL_INVESTIGATOR

NYU Langone Medical Center

Study Locations (Sites)

NYU Langone Health

New York, New York, 10017

United States

Collaborators and Investigators

Sponsor: NYU Langone Health

Eduardo Rodriguez, MD, DDS, PRINCIPAL_INVESTIGATOR, NYU Langone Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-17

Study Completion Date2026-01-01

Study Record Updates

Study Start Date2019-06-17

Study Completion Date2026-01-01

Terms related to this study

Keywords Provided by Researchers

Transplants
Transplantation
Craniomaxillofacial Transplantation
Upper Extremity Transplantation
Vascularized Composite Allotransplantation (VCA)

Additional Relevant MeSH Terms

Face Injuries
Hand Injuries
Craniofacial Injuries
Upper Extremity Injuries
Facial Injuries
Facial Deformity