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Human Craniomaxillofacial Allotransplantation

Phase 2
18 Years
60 Years
Open (Enrolling)
Facial Injuries, Traumatic Wounds and Injuries, Craniofacial Injuries, Craniofacial Defects

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Trial Information

Human Craniomaxillofacial Allotransplantation

Inclusion Criteria:

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

- Male or female and of any race, color, or ethnicity.

- Aged 18-60 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.

- No co-existing medical condition which, in the opinion of the study team, could
affect the immunomodulatory protocol, surgical procedure, or functional results (see
Exclusion Criteria below. If the condition is amenable to treatment, the study team
must agree that said condition should not significantly enhance the surgical risks of
full or partial craniomaxillofacial transplantation.)

- 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.

Exclusion Criteria:

- 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)

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

- 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 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,
Thallassemias, 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Graft Survival

Outcome Description:

Post-operative graft survival will be documented monthly Months 1-12 and quarterly (every 3 months) Years 2-5.

Outcome Time Frame:

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

Safety Issue:


Principal Investigator

W. P. Andrew Lee, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University


United States: Institutional Review Board

Study ID:




Start Date:

August 2012

Completion Date:

August 2022

Related Keywords:

  • Facial Injuries
  • Traumatic Wounds and Injuries
  • Craniofacial Injuries
  • Craniofacial Defects
  • Facial Injuries
  • Wounds and Injuries



Johns Hopkins University School of Medicine Baltimore, Maryland  21205