Facial and Arm Transplant for Severe Injuries

Overseen By Thomas Calahan, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Infection, Serious co-morbidities, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Surgical procedure with immediate post-operative care

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to assist individuals with severe face and arm injuries who have not found success with regular surgeries or prosthetics. It involves a transplant called Combined Craniomaxillofacial and Upper Extremity Allotransplantation, which merges facial and arm tissues to enhance appearance and function. The trial seeks individuals who have lost parts of their face and hands and are interested in this advanced transplant option. Participants must be HIV negative and willing to adhere to ongoing medical and psychological care plans before and after the transplant. As an unphased trial, this study provides a unique opportunity for patients to explore cutting-edge transplant options that may significantly improve their quality of life.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you must be willing to continue an immunosuppression regimen as directed by your treating physician.

What prior data suggests that this combined craniomaxillofacial and upper extremity allotransplantation is safe?

Research has shown that face and arm transplants can restore important functions and improve appearance for people with severe injuries. However, risks exist. Some patients have experienced serious health problems; for instance, three patients died after face transplants. One did not follow their medication plan, and another developed cancer.

Despite these risks, many patients have seen improvements in their lives. The treatment involves receiving tissue from a donor, requiring medication to prevent tissue rejection. Following the doctor's instructions closely is crucial to reduce risks.

Overall, while risks are present, many people find the benefits worthwhile. It's important to consult with doctors to understand both the potential benefits and risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this treatment because it offers a groundbreaking approach for individuals with severe facial and arm injuries. Unlike traditional methods, which might rely on prosthetics or reconstructive surgery, this treatment involves microvascular transplantation of both facial and upper extremity tissues, potentially restoring both form and function in a way that looks and feels natural. This technique could drastically improve quality of life by enabling better physical and emotional recovery compared to current options. Additionally, it represents a significant advancement in transplant medicine, using a unique combination of tissues to achieve results that were previously unattainable with existing treatments.

What evidence suggests that this combined face and upper extremity transplant could be effective for severe injuries?

Research shows that face and arm transplants can successfully restore important functions and appearance for people with severe injuries. These procedures improve both the appearance and movement of affected areas. Patients often regain feeling, enhancing their overall quality of life. The goal extends beyond appearance, aiming to make daily activities easier and more comfortable. In this trial, participants will undergo the combined craniomaxillofacial and upper extremity allotransplantation procedure, with only one treatment group and no randomization, placebo, or control groups. ^{2 3 4 6 7}

Who Is on the Research Team?

Eduardo Rodriguez, MD, DDS

Principal Investigator

NYU Langone Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I can attend all follow-up visits as required by the treatment plan.

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

I am willing to follow my doctor's instructions for my immunosuppression treatment.

Exclusion Criteria

You don't have a stable place to live or someone to support you.

You have serious other health problems.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo microvascular VCA transplantation from a non-living donor to restore function, appearance, and sensation to the face and upper extremity

Surgical procedure with immediate post-operative care

Follow-up

Participants are monitored for recovery and outcomes through clinical exams, x-rays, blood and tissue tests, and other evaluations

Monthly for 6 months, every 6 months for 2 years, then annually up to year 5

What Are the Treatments Tested in This Trial?

Interventions

• Combined Craniomaxillofacial and Upper Extremity Allotransplantation

Trial Overview 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.

How Is the Trial Designed?

Group I: Treatment group Experimental Treatment 1 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.

Combined Craniomaxillofacial and Upper Extremity Allotransplantation is already approved in United States for the following indications:

Approved in United States as Combined Craniomaxillofacial and Upper Extremity Allotransplantation for:

• Severe facial and upper extremity defects due to trauma, oncologic resection, or congenital deformity

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Composite tissue allotransplantation, including hand and facial tissue transplants, has become a clinical reality, providing new options for the estimated 7 million people in the USA needing complex tissue reconstruction each year.

The success of these transplants is largely due to the adaptation of immunotherapy techniques from kidney transplantation, highlighting that while the methods are innovative, many underlying surgical and immunological practices have been in use for a long time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Composite tissue allotransplantation of the hand and face: a new frontier in transplant and reconstructive surgery. Gander, B., Brown, CS., Vasilic, D., et al.[2022]

In a study involving 22 composite hemiface/mandible/tongue transplantations in rats, allografts treated with tapered cyclosporine A showed long-term survival of up to 385 days without rejection, indicating the efficacy of this immunosuppressive therapy.

The successful engraftment and maintenance of donor-specific chimerism in lymphoid organs and bone marrow were linked to the long-term survival of the allografts, suggesting that these factors are crucial for the success of complex tissue transplants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term survival of composite hemiface/mandible/tongue allografts correlates with multilineage chimerism development in the lymphoid and myeloid compartments of recipients. Kulahci, Y., Klimczak, A., Madajka, M., et al.[2010]

Face composite tissue allotransplantation has been successfully performed in 20 cases, providing excellent aesthetic and functional outcomes for patients with severe facial disfigurements, including those from burns and other traumatic injuries.

The procedure has shown good psychological acceptance among recipients and has established effective immunosuppressive regimens, making it a viable option in reconstructive surgery for severely disfigured patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Face allotransplantation and burns: a review. Arno, A., Barret, JP., Harrison, RA., et al.[2023]

In a study involving 36 rabbits, a new model for orthotopic composite hemiface/calvaria transplantation was developed, showing that low-dose cyclosporine A and prednisone can help prevent rejection of allografts, with five out of six treated rabbits surviving without rejection.

The study found that while untreated allografts were rejected within 7 to 10 days, the treatment group maintained viable bone and showed no significant difference in bone healing compared to autografts, indicating the potential for successful reconstruction of craniomaxillofacial defects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Establishing a new orthotopic composite hemiface/calvaria transplantation model in rabbits. Nie, C., Yang, D., Li, N., et al.[2021]

Facial allotransplantation has been successfully performed, showing that facial allografts can be reliable and their rejection can be managed with low-dose immunosuppression, allowing for restoration of oral and expressive functions.

The medium-term risk-benefit balance of facial transplants is acceptable, with evidence that the allograft integrates well into the recipient's body without causing donor identity transfer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current concepts and future challenges in facial transplantation. Lengelé, BG.[2009]

Composite tissue allotransplantation has shown promising results in reconstructive surgery, with nearly 50 hand transplants performed worldwide, emphasizing the importance of patient compliance and rehabilitation for successful outcomes.

Face transplantation has restored vital functions and aesthetics in patients, but it carries a significant risk, with a 20% estimated mortality rate within two years, highlighting the need for further research on the risks and benefits of different transplantation approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Face, upper extremity, and concomitant transplantation: potential concerns and challenges ahead. Siemionow, MZ., Zor, F., Gordon, CR.[2021]

Over seventy patients have successfully undergone upper extremity vascularized composite allotransplantation, achieving very good functional outcomes, indicating the procedure's efficacy in restoring limb function.

Twenty-five face transplants have been performed, showcasing significant functional and cosmetic improvements, but the field still faces challenges that need to be addressed before these techniques can be widely adopted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vascularized composite allotransplantation: an update on medical and surgical progress and remaining challenges. Murphy, BD., Zuker, RM., Borschel, GH.[2021]

Composite tissue allotransplantations, particularly for face and hand, are becoming more promising due to advancements in immunotherapy, which enhances the success of these complex surgeries.

The review highlights the need for further research to explore the benefits and challenges of simultaneous versus staged allotransplantation, especially regarding rehabilitation and cortical reorganization after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Concomitant face and hand transplantation: perfect solution or perfect storm? Gordon, CR., Zor, F., Cetrulo, C., et al.[2022]

Composite tissue allograft transplantation offers a potential solution for complex musculoskeletal defects when autologous tissue is not available, allowing for reconstruction of areas like the face, hand, or limbs in a single procedure.

The article discusses cell-based therapies that could minimize the need for chronic systemic immunosuppression, which is associated with significant side effects such as drug toxicity and increased risk of infections and cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cellular therapies for prolongation of composite tissue allograft transplantation. Sacks, JM., Horibe, EK., Lee, WP.[2007]

Citations

1. clinicaltrials.med.nyu.edu clinicaltrials.med.nyu.edu/clinicaltrial/1065/combined-craniomaxillofacial-upper-extremity/

Combined Craniomaxillofacial and Upper Extremity ... The purpose of this study is to evaluate functional and aesthetic outcomes of combined facial and upper extremity composite tissue allografts.

2. ctv.veeva.com ctv.veeva.com/study/craniomaxillofacial-and-upper-extremity-allotransplantation

Craniomaxillofacial and Upper Extremity Allotransplantation The purpose of this study is to evaluate functional and aesthetic outcomes of combined facial and upper extremity composite tissue allografts.

3. withpower.com withpower.com/trial/phase-arm-injuries-5-2019-a4c92

Facial and Arm Transplant for Severe Injuries Research shows that face and upper extremity transplants have been successful in restoring vital functions and appearance in patients with severe injuries.

4. app.trialscreen.org app.trialscreen.org/trials/face-injuries-craniomaxillofacial-upper-extremity-allotransplantation-trial-nct04057638

Craniomaxillofacial and Upper Extremity Allotransplantation Potential benefits include restored function, improved appearance, and regained sensation in the affected areas, leading to an enhanced quality of life. Risks:.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT01889381

Study Details | NCT01889381 | Human Craniomaxillofacial ... Specific Aims: 1) To establish face transplantation as a safe and effective reconstructive strategy for the treatment of devastating facial injuries/defects; 2) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04057638

Craniomaxillofacial and Upper Extremity Allotransplantation The purpose of this study is to evaluate functional and aesthetic outcomes of combined facial and upper extremity composite tissue allografts on patients ...

7. secure.arkansasbluecross.com secure.arkansasbluecross.com/members/report.aspx?policyNumber=2013011&viewIntro=yes

Transplant, Composite Tissue Allotransplantation, Hand ... Three patients died following face transplants; 1 was non-compliant with immunosuppressive treatment, 1 had secondary squamous cell carcinoma of the hypopharynx ...