Human Craniomaxillofacial Allotransplantation

This study is looking for 15 people aged 18-65 who have had a facial injury, whether recent or many years ago, and are interested in a face transplant. It aims to test a new approach for face transplants using bone marrow cell-based therapy and a single drug to prevent rejection, instead of the usual three drugs. The main goal is to see if the transplanted face (graft) survives for up to five years. This research hopes to make face transplants more widely available by reducing the need for strong, lifelong medications that can have side effects.

Study design: This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 15 participants.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for graft survival from the time of transplantation through the end of the study period, which can be up to 5 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Human Craniomaxillofacial Allotransplantation

Recruiting

PHASE2Ages 18–65InterventionalTreatment

Johns Hopkins University

~15 participants

Updated 2026-08-25 on ClinicalTrials.gov

What's tested:Bone marrow cell-based therapy & 1-drug immunosuppression.

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Graft Survival

Measured over Transplantation through end of study period (up to 5 years)

Conditions

Facial Injuries

Traumatic Wounds and Injuries

Craniofacial Injuries

Craniofacial Defects

Facial Transplantation

Facial Deformity

Where it's being run

1 sites across 1 states

Maryland1

Study leadership

Damon Cooney, MD, PHD · PRINCIPAL_INVESTIGATOR · Johns Hopkins University

Who to contact

Jane Littleton, CRNP, MSN

[email protected]

410-955-6875

Email the study team

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Eligibility criteria

Inclusion

Recent (≥6 months) or remote (i.e., several decades) craniomaxillofacial injury

Male or female and 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 by having never smoked or having quit \>6 consecutive months prior to screening.

Exclusion

No co-existing psycho-social problems (i.e., alcoholism, drug abuse).

Negative for malignancy for past 5 years.

Negative for HIV at transplant.

Negative crossmatch with donor.

If female of child-bearing potential, negative serum pregnancy test.

If female of child-bearing potential, consent to use reliable contraception for at least one year following transplantation.

Consents to cell collection, storage, and bone marrow infusion as part of the treatment regime.

USA citizen or equivalent.

Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.

Positive for any of the following conditions:

Untreated sepsis.

HIV (active or seropositive).

Active tuberculosis.

Active Hepatitis B infection.

Hepatitis C.

Viral encephalitis.

Toxoplasmosis.

Malignancy (within past 5 years).

Current/recent (within 3 months of donation/screening consent) IV drug abuse.

Paralysis of ischemic, traumatic, or congenital origin.

Infectious, post infectious, or inflammatory (axonal or demyelinating) neuropathy.

Toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent exposure).

Mixed connective tissue disease.

Conditions that, in the opinion of the study team, may impact the immunomodulatory protocol potentially exposing the recipient to an unacceptable risk under immunosuppressive treatment.

A history of medical non-compliance.

Sensitized recipients with high levels (50%) of panel-reactive Human Leukocyte Antigen (HLA) antibodies.

Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.

Mixed connective tissue diseases and collagen diseases can result in poor wound healing after surgery.

Conditions that may impact functional outcomes including Lipopolysaccharidosis and amyloidosis (may impact nerve regeneration) or rare disorders of bone healing like osteopetrosis.

Subjects with inadequate donor sites for autologous reconstruction in the event of post-transplant flap failure.

Patients considered unsuitable per the consulted Psychiatric/ Psychologic appraisal.

What this trial measures

Graft SurvivalTransplantation through end of study period (up to 5 years)
Post-operative graft survival will be documented monthly Months 1-12 and quarterly (every 3 months) Years 2-5.

Trialytics