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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

Must not have

Congenital Abnormalities: co-existent absence/atrophy/agenesis of any tissue may affect post-transplant results

Active malignancy within 5 years with the exclusion of non-melanoma

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

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a birth defect that could affect my surgery results.

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I haven't had cancer, except for non-melanoma skin cancer, in the last 5 years.

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I have an amputation above my elbow but can still use some shoulder muscles.

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I am able to understand and agree to the study's procedures and risks.

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I have cognitive issues due to a brain injury or neurological disorder.

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I do not have any severe infections or diseases that would prevent me from undergoing a transplant.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 11Eligibility criteria met