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Procedure

Face Transplant for Facial 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

Subjects must have autogenous tissue options available for reconstruction in event of graft failure

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 until year 5

Awards & highlights

Study Summary

This trial aims to provide face transplants for people who have severe facial trauma and evaluate how well they function.

Who is the study for?

This trial is for adults aged 18-64 with severe facial trauma needing a face transplant. Candidates must be healthy enough for surgery, willing to follow post-surgery treatment plans including immunosuppression, and able to attend follow-up visits. Women of childbearing age must test negative for pregnancy and use contraception post-transplant.Check my eligibility

What is being tested?

The study involves performing face transplants on individuals with significant facial injuries to improve appearance and restore function, movement, and sensation. The process includes pre-and post-operative evaluations by various specialists.See study design

What are the potential side effects?

Potential side effects include those related to the surgical procedure itself as well as complications from long-term immunosuppression such as increased risk of infections, possible organ damage, and potential rejection of the transplanted tissue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have my own tissue available for reconstruction if the first surgery doesn't work.

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I can complete all needed exams and screenings before a transplant.

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I am between 18 and 64 years old.

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My kidney function is normal.

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I need a face transplant due to severe facial tissue damage.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and monthly for 6 months, every 6 months for 2 years, then annually up to year 5 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Evaluate the success of the face transplant

Secondary outcome measures

Evaluate psychological effects of receiving a face transplant

Trial Design

1Treatment groups

Experimental Treatment

Group I: Face Transplant recipientExperimental Treatment1 Intervention

Single Arm study, all participants will receive Craniomaxillofacial allotransplantation

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,368 Previous Clinical Trials

839,716 Total Patients Enrolled

1 Trials studying Facial Injuries

10 Patients Enrolled for Facial Injuries

Eduardo Rodriguez, MD, DDSPrincipal InvestigatorNYU Langone Medical Center

1 Previous Clinical Trials

10 Total Patients Enrolled

1 Trials studying Facial Injuries

10 Patients Enrolled for Facial Injuries

Media Library

Craniomaxillofacial allotransplantation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02158793 — N/A

Facial Injuries Research Study Groups: Face Transplant recipient

Facial Injuries Clinical Trial 2023: Craniomaxillofacial allotransplantation Highlights & Side Effects. Trial Name: NCT02158793 — N/A

Craniomaxillofacial allotransplantation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02158793 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially be eligible to participate in this clinical investigation?

"This clinical trial seeks 10 suitable participants of any gender between the ages 18 and 64. These individuals should have endured facial traumas, as determined by a plastic surgeon, that necessitate transplantation surgery. Other criteria include willingness to participate in post-operative psychiatric evaluations, approval from Patient Selection Committee for placement on recipient waiting list, adherence to immunosuppression regimen prescribed by treating physician, ability to attend follow-up visits per treatment plan and access to autogenous tissue options if graft fails."

Answered by AI

Does this trial accept applicants over the age of 18?

"The research team is looking for participants aged 18 to 64 years old."

Answered by AI

How many participants are engaged in this research endeavor?

"Affirmative. According to information available on clinicaltrials.gov, this research project is currently recruiting participants who have been previously posted on June 1st 2014 and last updated October 3rd 2022. This study requires 10 patients from a single site for its completion."

Answered by AI

Is there still capacity for participants in this experiment?

"Confirmed. Per details on clinicaltrials.gov, recruitment for this medical trial is currently taking place with the initial posting being dated June 1st 2014 and a recent update occurring October 3rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Craniomaxillofacial Allotransplantation

2014. "Craniomaxillofacial Allotransplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02158793.