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New treatment option for Face Injuries
Official title Craniomaxillofacial and Upper Extremity Allotransplantation
ClinicalTrials.gov ID: NCT04057638
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 64
You may be able to join 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...
- Missing part of one or both hands and forearms.
- Must be HIV negative at the time of transplant.
You likely can't join if
- 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: people with a score...
- Body Dysmorphic disorder (see Appendix N.2 for screening tool). Less severe psychiatric conditions are addressed on a case by case basis
See the full eligibility criteria
Who can 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...
- 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.
- people 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.
What rules you out
- 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: people 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
- people 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...
- Blindness: blind amputees may be poor candidates because sensory return in the hand may not provide sufficient protective sensation
- Pregnancy
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.