Upper-extremity transplantation using a cell-based protocol to minimize immunosuppression.
Stefan Schneeberger, Vijay S Gorantla, Gerald Brandacher...
https://pubmed.ncbi.nlm.nih.gov/23001085Actively Recruiting
Phase 2
Age: 18Years - 65Years
All Genders
ID01889381
Human Craniomaxillofacial Allotransplantation for Severe Facial Injuries Using Novel Immunomodulatory Protocol with Bone Marrow Cell Therapy and Single-Drug Immunosuppression
Led by Johns Hopkins University · Updated on 2025-08-14
15
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to establish face transplantation as a safe and effective reconstructive option for individuals with severe facial injuries or defects. The study evaluates a new immunomodulatory protocol, known as the Pittsburgh or Starzl Protocol, designed to minimize the need for long-term, high-dose immunosuppression, which traditionally carries risks like infection and cancer. This Phase II clinical trial plans to perform 15 full or partial face transplants using this approach to improve patient outcomes and quality of life. The treatment involves combining face transplantation with a novel donor bone marrow cell-based therapy followed by maintenance with a single immunosuppressive drug, tacrolimus. Patients first receive T-cell depletion with alemtuzumab, then the transplant is performed, and donor bone marrow cells are infused about 10 days later. Tacrolimus is given for at least six months before a gradual reduction might be considered in stable patients. Participants will be closely monitored throughout the study, which may last up to five years after transplantation. Researchers will assess graft survival as the primary measure, along with the immunosuppression levels needed to maintain the graft. The study includes evaluations of rejection risk, functional and aesthetic outcomes, and patient adherence to the protocol, aiming to support wider clinical use of face transplantation with fewer side effects.
CONDITIONS
Brief Title
Human Craniomaxillofacial Allotransplantation
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Recent (≥6 months) or remote (several decades) craniomaxillofacial injury
- Male or female 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 as never smoked or quit more than 6 months prior to screening
- No co-existing medical conditions affecting treatment or surgery
- No co-existing psychosocial problems such as alcoholism or drug abuse
- Negative for malignancy in the past 5 years
- Negative for HIV at transplant
- Negative crossmatch with donor
- For females of child-bearing potential, negative pregnancy test and consent to reliable contraception for at least one year post-transplant
- Consents to cell collection, storage, and bone marrow infusion as part of treatment
- USA citizen or equivalent
- Agrees to comply with the protocol and immunomodulatory treatment regimen
You will not qualify if you...
- Untreated sepsis
- Active or seropositive HIV infection
- Active tuberculosis
- Active Hepatitis B infection
- Hepatitis C
- Viral encephalitis
- Toxoplasmosis
- Malignancy within past 5 years
- Current or recent (within 3 months) intravenous drug abuse
- Paralysis of ischemic, traumatic, or congenital origin
- Infectious, post-infectious, or inflammatory neuropathy
- Toxic neuropathy from heavy metals, drugs, or industrial agents
- Mixed connective tissue disease
- Conditions increasing risk under immunosuppressive treatment as judged by study team
- History of medical non-compliance
- Sensitized recipients with high panel-reactive HLA antibodies (≥50%)
- Conditions increasing surgical risk or postoperative complications including inherited coagulopathies
- Conditions affecting wound healing or nerve regeneration such as Lipopolysaccharidosis, amyloidosis, osteopetrosis
- Inadequate donor sites for autologous reconstruction if transplant fails
- Psychiatric or psychological conditions making patient unsuitable according to appraisal
AI-Screening
AI-Powered Screening
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1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Tacrolimus therapy given for at least 6 months before spaced weaning is considered
Participants undergo face transplantation combined with novel bone marrow cell-based therapy followed by single-drug immunosuppression with potential weaning.
Initial transplant procedure followed by approximately weekly visits for up to 6 months
Follow-up
Duration - Up to 5 years
Participants are monitored for graft survival and immunosuppression requirements for up to 5 years after transplantation.
Periodic visits for up to 5 years post-transplant
Trial Site Locations
Total: 1 location
1
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21287
Actively Recruiting
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Research Team
J
Jane Littleton, CRNP, MSN
T
TBD TBD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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