Transplanting face and arm tissue to improve function and appearance
Combined Craniomaxillofacial and Upper Extremity Allotransplantation
This study is testing a new surgery that transplants tissue from a donor to help people with serious facial and arm injuries improve their function and appearance when other treatments haven't worked.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 64 Years |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT04057638 on ClinicalTrials.gov |
What this trial studies
This study evaluates the outcomes of a surgical procedure that involves transplanting tissue from a deceased donor to patients with severe facial and upper extremity injuries who have not benefited from traditional reconstructive surgeries or prosthetics. The combined craniomaxillofacial and upper extremity allotransplantation aims to restore function, appearance, and sensation in affected areas. Participants will undergo clinical assessments, imaging, and laboratory tests to monitor recovery and outcomes following the transplant. The study seeks to gather comprehensive data on the effectiveness of this innovative approach.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-64 with severe facial and upper extremity injuries who have not achieved satisfactory results from previous surgeries or prosthetics.
Not a fit: Patients with injuries that are not severe enough to require transplantation or those who have not attempted prosthetic solutions may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could significantly enhance the quality of life for patients with severe facial and upper extremity injuries by restoring both function and aesthetic appearance.
How similar studies have performed: Other studies involving vascularized composite allotransplantation have shown promising results, indicating that this approach may be effective in restoring function and aesthetics in similar patient populations.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion 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. Exclusion Criteria: * 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
Where this trial is running
New York, New York
- NYU Langone Health — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Eduardo Rodriguez, MD, DDS — NYU Langone Medical Center
- Study coordinator: Thomas Calahan, BA
- Email: Thomas.Calahan@nyulangone.org
- Phone: (929) 455-5826
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.