Human Craniomaxillofacial Allotransplantation
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 60 |
| Updated: | 10/10/2018 |
| Start Date: | August 2012 |
| End Date: | August 2026 |
| Contact: | Jane Littleton, CRNP, MSN |
| Email: | jlittl38@jhmi.edu |
| Phone: | 410-955-6875 |
Background: The human face is critically important for breathing, eating, seeing, and
speaking/ communicating, but its most important job may be to look like a human face.
Devastating facial deformities often cause affected individuals to avoid human contact and
disappear from society. Although current surgical advancements can somewhat restore facial
defects, this process often requires many operations and the resulting face only resembles
the human face. To date, over 20 face transplants have been performed with highly encouraging
functional and aesthetic results, but widespread clinical use has been limited due to the
adverse effects of life-long and high-dose immunosuppression needed to prevent graft
rejection. Risks include infection, cancer, and metabolic problems, all of which can greatly
affect recipients' quality of life, make the procedure riskier, and jeopardize the potential
benefits of face transplantation.
Study Design: This non-randomized, Phase II clinical trial will document the use of a new
immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing face
transplantation as a safe and effective reconstructive treatment for devastating injuries/
defects by minimizing maintenance immunosuppression therapy in face transplant patients. This
protocol combines lymphocyte depletion with donor bone marrow cell infusion and has enabled
graft survival using low doses of a single immunosuppressive drug followed by weaning of
treatment. Initially designed for living-related solid organ donation, this regimen has been
adapted for use with grafts donated by deceased donors. The investigators propose to perform
15 full or partial human face transplants employing this novel protocol.
Specific Aims: 1) To establish face transplantation as a safe and effective reconstructive
strategy for the treatment of devastating facial injuries/defects; 2) To reduce the risk of
rejection and enable allograft survival while minimizing the requirement for long-term,
high-dose, multi-drug immunosuppression.
Significance of Research: Face transplantation could help injured individuals recover
functionality, self-esteem, and the ability to reintegrate into family and social life as
"whole" individuals. This protocol offers the potential for minimizing the morbidity of
maintenance immunosuppression, thereby beneficially shifting the risk/benefit ratio of this
life-enhancing procedure and enabling a wider clinical application of face transplantation.
speaking/ communicating, but its most important job may be to look like a human face.
Devastating facial deformities often cause affected individuals to avoid human contact and
disappear from society. Although current surgical advancements can somewhat restore facial
defects, this process often requires many operations and the resulting face only resembles
the human face. To date, over 20 face transplants have been performed with highly encouraging
functional and aesthetic results, but widespread clinical use has been limited due to the
adverse effects of life-long and high-dose immunosuppression needed to prevent graft
rejection. Risks include infection, cancer, and metabolic problems, all of which can greatly
affect recipients' quality of life, make the procedure riskier, and jeopardize the potential
benefits of face transplantation.
Study Design: This non-randomized, Phase II clinical trial will document the use of a new
immunomodulatory protocol (aka - Pittsburgh Protocol, Starzl Protocol) for establishing face
transplantation as a safe and effective reconstructive treatment for devastating injuries/
defects by minimizing maintenance immunosuppression therapy in face transplant patients. This
protocol combines lymphocyte depletion with donor bone marrow cell infusion and has enabled
graft survival using low doses of a single immunosuppressive drug followed by weaning of
treatment. Initially designed for living-related solid organ donation, this regimen has been
adapted for use with grafts donated by deceased donors. The investigators propose to perform
15 full or partial human face transplants employing this novel protocol.
Specific Aims: 1) To establish face transplantation as a safe and effective reconstructive
strategy for the treatment of devastating facial injuries/defects; 2) To reduce the risk of
rejection and enable allograft survival while minimizing the requirement for long-term,
high-dose, multi-drug immunosuppression.
Significance of Research: Face transplantation could help injured individuals recover
functionality, self-esteem, and the ability to reintegrate into family and social life as
"whole" individuals. This protocol offers the potential for minimizing the morbidity of
maintenance immunosuppression, thereby beneficially shifting the risk/benefit ratio of this
life-enhancing procedure and enabling a wider clinical application of face transplantation.
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)
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.
We found this trial at
1
site
733 North Broadway
Baltimore, Maryland 21205
Baltimore, Maryland 21205
(410) 955-3182
Principal Investigator: W. P. Andrew Lee, MD
Phone: 443-287-4629
Johns Hopkins University School of Medicine Johns Hopkins Medicine (JHM), headquartered in Baltimore, Maryland, is...
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