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New treatment option for Facial Injuries
Official title Human Craniomaxillofacial Allotransplantation
ClinicalTrials.gov ID: NCT01889381
What this study is testing
What is Bone marrow cell-based therapy & 1-drug immunosuppression.?
Bone marrow cell-based therapy & 1-drug immunosuppression. is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for facial injuries.
Also referred to as Deceased donor face transplantation.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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.
You likely can't join if
- below. If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks...
- 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.
See the full eligibility 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
- 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...
- 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.
- people with inadequate donor sites for autologous reconstruction in the event of post-transplant flap failure.
- Patients considered unsuitable per the consulted Psychiatric/ Psychologic appraisal.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.