What is this study trying to find out about facial transplantation?

This study is evaluating a new treatment approach to improve face transplantation safety and effectiveness for severe facial injuries. It focuses on reducing the need for long-term, high-dose immunosuppression that can cause serious side effects. Johns Hopkins University is leading the research to help patients regain function and appearance with fewer risks.

Who may be eligible for this facial transplantation clinical trial?

Adults aged 18 to 65 with recent or older severe facial injuries may qualify. Both men and women of any race can participate. Key requirements include a strong desire for transplantation, being a non-smoker for over six months, and having no active infections or serious medical or psychosocial problems. Please review eligibility criteria for more details.

Is there any cost to participate in this facial transplantation clinical trial?

Study-related care, including the transplant procedure, immunosuppressive treatment, and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should consider these potential costs when deciding to join.

Actively Recruiting

Phase 2

Age: 18Years - 65Years

All Genders

ID01889381

Human Craniomaxillofacial Allotransplantation for Severe Facial Injuries Using Novel Immunomodulatory Protocol with Bone Marrow Cell Therapy and Single-Drug Immunosuppression

Led by Johns Hopkins University · Updated on 2025-08-14

Participants Needed

Research Sites

260 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to establish face transplantation as a safe and effective reconstructive option for individuals with severe facial injuries or defects. The study evaluates a new immunomodulatory protocol, known as the Pittsburgh or Starzl Protocol, designed to minimize the need for long-term, high-dose immunosuppression, which traditionally carries risks like infection and cancer. This Phase II clinical trial plans to perform 15 full or partial face transplants using this approach to improve patient outcomes and quality of life. The treatment involves combining face transplantation with a novel donor bone marrow cell-based therapy followed by maintenance with a single immunosuppressive drug, tacrolimus. Patients first receive T-cell depletion with alemtuzumab, then the transplant is performed, and donor bone marrow cells are infused about 10 days later. Tacrolimus is given for at least six months before a gradual reduction might be considered in stable patients. Participants will be closely monitored throughout the study, which may last up to five years after transplantation. Researchers will assess graft survival as the primary measure, along with the immunosuppression levels needed to maintain the graft. The study includes evaluations of rejection risk, functional and aesthetic outcomes, and patient adherence to the protocol, aiming to support wider clinical use of face transplantation with fewer side effects.

CONDITIONS

Brief Title

Human Craniomaxillofacial Allotransplantation

Who Can Participate

Age: 18Years - 65Years

All Genders

Eligibility Criteria

You may qualify if you...

Recent (≥6 months) or remote (several decades) craniomaxillofacial injury
Male or female of any race, color, or ethnicity
Aged 18-65 years
Strong desire to undergo craniomaxillofacial transplantation
Completes the protocol informed consent form
Non-smoker, defined as never smoked or quit more than 6 months prior to screening
No co-existing medical conditions affecting treatment or surgery
No co-existing psychosocial problems such as alcoholism or drug abuse
Negative for malignancy in the past 5 years
Negative for HIV at transplant
Negative crossmatch with donor
For females of child-bearing potential, negative pregnancy test and consent to reliable contraception for at least one year post-transplant
Consents to cell collection, storage, and bone marrow infusion as part of treatment
USA citizen or equivalent
Agrees to comply with the protocol and immunomodulatory treatment regimen

You will not qualify if you...

Untreated sepsis
Active or seropositive HIV infection
Active tuberculosis
Active Hepatitis B infection
Hepatitis C
Viral encephalitis
Toxoplasmosis
Malignancy within past 5 years
Current or recent (within 3 months) intravenous drug abuse
Paralysis of ischemic, traumatic, or congenital origin
Infectious, post-infectious, or inflammatory neuropathy
Toxic neuropathy from heavy metals, drugs, or industrial agents
Mixed connective tissue disease
Conditions increasing risk under immunosuppressive treatment as judged by study team
History of medical non-compliance
Sensitized recipients with high panel-reactive HLA antibodies (≥50%)
Conditions increasing surgical risk or postoperative complications including inherited coagulopathies
Conditions affecting wound healing or nerve regeneration such as Lipopolysaccharidosis, amyloidosis, osteopetrosis
Inadequate donor sites for autologous reconstruction if transplant fails
Psychiatric or psychological conditions making patient unsuitable according to appraisal

Research Team

Jane Littleton, CRNP, MSN

TBD TBD

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