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Composite Tissue Allotransplantation
Facial and Arm Transplant for Severe Injuries
N/A
Recruiting
Led By Eduardo Rodriguez, MD, DDS
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
The subject is able to complete pre-transplant examination and screening procedures
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Awards & highlights
Study Summary
This trial is testing a new way to reconstruct faces and upper extremities using a combination of skin, bone, muscle, and blood vessels from donors. The goal is to improve function and appearance for patients who haven't had success with other methods.
Who is the study for?
This trial is for adults aged 18-64 with severe facial and upper extremity injuries that haven't improved with standard surgery or prosthetics. Candidates must be HIV negative, have a normal kidney function, agree to contraception if applicable, and commit to psychiatric evaluations and follow-up visits. Exclusions include uncontrolled infections, serious illnesses, certain amputations, pregnancy, severe psychiatric issues or substance abuse disorders.Check my eligibility
What is being tested?
The study tests combined face and hand/forearm transplants in patients who've had inadequate results from usual reconstructive surgeries. It aims to assess how well these complex transplants improve appearance and function. Participants will undergo extensive pre- and post-surgery evaluations.See study design
What are the potential side effects?
While specific side effects are not listed here, transplant recipients typically face risks like rejection of the new tissue (requiring lifelong immunosuppression medication), infection due to lowered immunity from drugs taken after surgery, possible complications from anesthesia during the operation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I need a face transplant due to severe facial tissue loss around my mouth, eyes, or nose.
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I can undergo all required exams and screenings before a transplant.
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I have my own tissue available for reconstruction if the first surgery doesn't work.
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I am missing part of one or both of my hands and forearms.
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My kidney function is normal.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monthly for 6 months, every 6 months for 2 years, then annually up to year 5
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in appearance of the transplanted facial segment
Change in appearance of the upper extremity transplant
Change in function of the transplanted facial segment
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment groupExperimental Treatment1 Intervention
There will only be the treatment group in this study, which undergoes microvascular VCA transplantation. There will be no randomization, placebo or control groups.
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,368 Previous Clinical Trials
839,716 Total Patients Enrolled
Eduardo Rodriguez, MD, DDSPrincipal InvestigatorNYU Langone Medical Center
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can attend all follow-up visits as required by the treatment plan.You don't have a stable place to live or someone to support you.You have serious other health problems.I am willing to follow my doctor's instructions for my immunosuppression treatment.I have a birth defect that could affect my surgery results.You have a mental health condition that could make the transplant unsafe or less likely to work.I haven't had cancer, except for non-melanoma skin cancer, in the last 5 years.I have an amputation above my elbow but can still use some shoulder muscles.I need a face transplant due to severe facial tissue loss around my mouth, eyes, or nose.You have smoked within the past year.I can undergo all required exams and screenings before a transplant.I have tried using a prosthetic if my amputation was less than 6 months ago, unless it's not possible due to surgery needs.You currently have a serious mental health condition that is not well controlled.The crossmatch test is negative before the transplant.I have my own tissue available for reconstruction if the first surgery doesn't work.You have HIV or Hepatitis B.I am able to understand and agree to the study's procedures and risks.I have cognitive issues due to a brain injury or neurological disorder.You have a problem with drugs or alcohol that is not currently being managed.You have not been following your doctor's instructions for taking your medication.I am missing part of one or both of my hands and forearms.I am willing to undergo mental health evaluations before and after transplant surgery.I do not have any severe infections or diseases that would prevent me from undergoing a transplant.You have body dysmorphic disorder, which can be checked using a specific screening tool. Other less severe mental health conditions will be considered individually.I am blind and have an amputation, which may affect my hand's sensitivity.I am between 18 and 64 years old.My kidney function is normal.You must not have HIV when undergoing the transplant.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are geriatric individuals being considered for enrollment in this clinical trial?
"As outlined by the criteria for inclusion, individuals must be 18 or older but no more than 64 years of age to qualify for this medical trial."
Answered by AI
Are there any available slots for patient participation in this research?
"This research endeavour, which was first announced on June 17th 2019 and subsequently edited on the 10th of June 2022, is in search for participants as indicated by clinicaltrials.gov."
Answered by AI
Can I meet the criteria to participate in this research?
"For this clinical trial, investigators are looking to recruit 10 individuals aged 18-64 who have experienced hand injuries. Furthermore, they must fulfill the following criteria: sign and date all required Institutional Review Board (IRB) approved consent forms; possess a facial composite tissue defect as assessed by their Plastic Surgeon that necessitates a face transplant; lack at least one part of either or both arms/hands caused non-repairable peri-nasal, orbital, and oral damage; be HIV negative before being transplanted; pass crossmatch test prior to surgery; receive second opinions from specialists in upper extremity reconstruction and facial reconstruction respectively;"
Answered by AI
What is the capacity of enrollees for this experiment?
"Indeed, the clinicaltrials.gov website confirms that this research endeavour is presently seeking out suitable candidates. The trial was first launched on June 17th 2019 and has since been revised as of 10th June 2022. There are currently spaces for 10 test subjects at a single location."
Answered by AI
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