Can a bone marrow trick make face transplants safer?
NCT ID NCT01889381
First seen Aug 11, 2026 · Last updated Aug 26, 2026 · Updated 3 times
Summary
This trial tests a new approach to face transplantation that aims to reduce the need for lifelong, high-dose immunosuppressive drugs. The method combines a bone marrow cell infusion with a single low-dose immunosuppressant, potentially lowering the risk of infection, cancer, and other side effects. Researchers plan to perform 15 full or partial face transplants in people with severe facial injuries or defects. The goal is to see if this strategy can help the transplanted face survive while minimizing the burden of immunosuppression.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Bone marrow cell-based therapy combined with a single immunosuppressive drug (tacrolimus) and initial T-cell depletion with alemtuzumab
- What this could lead to
- If successful, this could make face transplantation safer and more accessible, reducing the need for lifelong high-dose immunosuppression and improving quality of life for people with severe facial injuries.
- What could go wrong
- This is an early-phase trial with a small number of participants. The approach may not prevent rejection in all cases, and immunosuppression still carries risks of infection, cancer, and metabolic issues.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 15 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2012
- Expected to finish
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Aug 2041
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Recent (≥6 months) or remote (i.e., several decades) craniomaxillofacial injury * Male or female and of any race, color, or ethnicity. * Aged 18-65 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. * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Johns Hopkins University School of Medicine
RECRUITINGBaltimore, Maryland, 21287, United States
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