[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"facial-deformity\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:facial-deformity":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,52,79],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100366928","craniomaxillofacial-and-upper-extremity-allotransplantation-100366928",false,"NCT04057638","Craniomaxillofacial and Upper Extremity Allotransplantation","Combined Craniomaxillofacial and Upper Extremity Allotransplantation","Inclusion Criteria:\n\n* Signed and dated all required Institutional Review Board (IRB) approved consent forms.\n* Male or female recipient between the ages of 18-64 years. Recipients do not need to be of the same sex as the donor.\n* Facial composite tissue defect requiring facial transplantation as determined by the treating Plastic and Reconstructive Surgeon. Inclusive facial functional subunit tissue loss. Including but not limited to irreparable peri-oral, peri-orbital, and peri-nasal damage.\n* Missing part of one or both hands and forearms.\n* Must be HIV negative at the time of transplant.\n* Crossmatch is negative at the time of transplant.\n* Patient has been encouraged to seek a second opinion from a Plastic Surgeon with specialized focus in facial reconstruction.\n* Patient has been encouraged to seek a second opinion from a Plastic Surgeon with specialized focus in upper extremity reconstruction.\n* Willingness to participate in ongoing psychiatric, psychological and social work evaluations prior to and post-transplant surgery.\n* The subject is able to complete pre-transplant examination and screening procedures.\n* Patient has been approved by Patient Selection Committee for placement on the recipient waiting list.\n* The subject is willing to continue immunosuppression regimen as directed by treating physician.\n* Subject is willing and able to return to follow-up visits as described in treatment plan.\n* Subjects must have autogenous tissue options available for reconstruction in event of graft failure.\n* Normal glomerular filtration rate (GFR) \\>60.\n* Negative pregnancy test within 48hrs of transplant for women of childbearing age and who agree to use a reliable form of contraception for one year following transplant.\n\nExclusion Criteria:\n\n* Uncontrolled infection or severe concomitant diseases which would exclude the recipient from transplantation\n* Serious co-morbidities\n* Positive serology for HIV; Hepatitis B Antigen\n* Active malignancy within 5 years with the exclusion of non-melanoma\n* Substance abuse disorders not currently under control (as determined by the Michigan Alcohol Screening Test - see Appendix N.1: Subjects with a score of 3 or more will be excluded)\n* Body Dysmorphic disorder (see Appendix N.2 for screening tool). Less severe psychiatric conditions are addressed on a case by case basis\n* Active Severe Psychiatric Illness\n* Cognitive limitations affecting the patient's ability to provide informed consent\n* Recent history of medical non-adherence\n* Unstable social situation as evidence by lack of stable housing and\u002For lack of a supportive significant other.\n* Recent history of medical non-adherence.\n* Lack of stable housing and\u002For supportive significant other\u002Fcaregiver throughout all phases of the study\n* Currently active smoker within 1 year\n* Subjects with any cognitive deficits related to a traumatic brain injury (TBI) and or any organic neurological disorders\n* Any other psychological status that would hinder the success or safety of the transplantation.\n* Level of amputation proximal to mid-humerus: some presence of proximal muscles is required to motor a functioning hand.\n* Congenital Abnormalities: co-existent absence\u002Fatrophy\u002Fagenesis of any tissue may affect post-transplant results\n* History of amputation of less than six months: subject must be allowed to attempt prosthetic use prior to hand transplantation. This can be waived in cases where the recipient requires amputation\u002Frevision of the transplant site at the time of transplantation. However, if at all possible, it is highly encouraged that the patient has ruled out prosthetics as an alternative to transplantation.\n* Blindness: blind amputees may be poor candidates because sensory return in the hand may not provide sufficient protective sensation\n* Pregnancy","ALL","18 Years","64 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"NA","The purpose of this study is to evaluate functional and aesthetic outcomes of combined facial and upper extremity composite tissue allografts on patients who have not achieved functional and aesthetic outcomes with conventional reconstructive surgical strategies and prosthetic devices.",[27,28,29,30,31,32],"Face Injuries","Hand Injuries","Craniofacial Injuries","Upper Extremity Injuries","Facial Injuries","Facial Deformity",[34,35,36,37,38],"Transplants","Transplantation","Craniomaxillofacial Transplantation","Upper Extremity Transplantation","Vascularized Composite Allotransplantation (VCA)","RECRUITING","2025-12-08",{"date":42,"type":43},"2025-12-16","ACTUAL",{"date":45,"type":43},"2019-06-17",{"date":47,"type":21},"2026-01-01",{"name":49,"class":50},"NYU Langone Health","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":63,"conditions":64,"keywords":68,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":51},"100200733","phase-2-human-craniomaxillofacial-allotransplantation-100200733","NCT01889381","Human Craniomaxillofacial Allotransplantation","Inclusion Criteria:\n\n* Recent (≥6 months) or remote (i.e., several decades) craniomaxillofacial injury\n* Male or female and of any race, color, or ethnicity.\n* Aged 18-65 years.\n* Strong desire to undergo craniomaxillofacial transplantation.\n* Completes the protocol informed consent form.\n* Non-smoker, defined by having never smoked or having quit \\>6 consecutive months prior to screening.\n* 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.)\n* No co-existing psycho-social problems (i.e., alcoholism, drug abuse).\n* Negative for malignancy for past 5 years.\n* Negative for HIV at transplant.\n* Negative crossmatch with donor.\n* If female of child-bearing potential, negative serum pregnancy test.\n* If female of child-bearing potential, consent to use reliable contraception for at least one year following transplantation.\n* Consents to cell collection, storage, and bone marrow infusion as part of the treatment regime.\n* USA citizen or equivalent.\n* Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regime.\n\nExclusion Criteria:\n\n* Positive for any of the following conditions:\n\n  * Untreated sepsis.\n  * HIV (active or seropositive).\n  * Active tuberculosis.\n  * Active Hepatitis B infection.\n  * Hepatitis C.\n  * Viral encephalitis.\n  * Toxoplasmosis.\n  * Malignancy (within past 5 years).\n  * Current\u002Frecent (within 3 months of donation\u002Fscreening consent) IV drug abuse.\n  * Paralysis of ischemic, traumatic, or congenital origin.\n  * Infectious, post infectious, or inflammatory (axonal or demyelinating) neuropathy.\n  * Toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent exposure).\n  * Mixed connective tissue disease.\n* 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.\n* A history of medical non-compliance.\n* Sensitized recipients with high levels (50%) of panel-reactive Human Leukocyte Antigen (HLA) antibodies.\n* 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.\n* Mixed connective tissue diseases and collagen diseases can result in poor wound healing after surgery.\n* Conditions that may impact functional outcomes including Lipopolysaccharidosis and amyloidosis (may impact nerve regeneration) or rare disorders of bone healing like osteopetrosis.\n* Subjects with inadequate donor sites for autologous reconstruction in the event of post-transplant flap failure.\n* Patients considered unsuitable per the consulted Psychiatric\u002F Psychologic appraisal.","65 Years",{"count":60,"type":21},15,[62],"PHASE2","Background: The human face is critically important for breathing, eating, seeing, and speaking\u002F 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.\n\nStudy 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\u002F 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.\n\nSpecific Aims: 1) To establish face transplantation as a safe and effective reconstructive strategy for the treatment of devastating facial injuries\u002Fdefects; 2) To reduce the risk of rejection and enable allograft survival while minimizing the requirement for long-term, high-dose, multi-drug immunosuppression.\n\nSignificance 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\u002Fbenefit ratio of this life-enhancing procedure and enabling a wider clinical application of face transplantation.",[31,65,29,66,67,32],"Traumatic Wounds and Injuries","Craniofacial Defects","Facial Transplantation",[31,69,67,32],"Face Transplant","2025-08-11",{"date":72,"type":43},"2025-08-14",{"date":74,"type":43},"2012-08",{"date":76,"type":21},"2031-08",{"name":78,"class":50},"Johns Hopkins University",{"id":80,"slug":81,"hasResults":11,"nctId":82,"briefTitle":83,"officialTitle":83,"acronym":4,"eligibilityCriteria":84,"healthyVolunteers":85,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":86,"targetDuration":4,"studyType":22,"phases":87,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":99,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":4},"100555023","optimizing-surgical-and-prosthetic-workflow-for-implant-supported-ear-and-nose-prostheses-with-early-loading-and-distant-prosthesis-fabrication-a-prospective-cohort-study-100555023","NCT06506695","Optimizing Surgical and Prosthetic Workflow for Implant-supported Ear and Nose Prostheses With Early Loading and Distant Prosthesis Fabrication: A Prospective Cohort Study","Inclusion Criteria:\n\n* Adult patients with a facial defect in the nasal and\u002For temporal area that will not be repaired with autologous tissue;\n* Adult patients receiving oncological resection or trauma resulting in a facial defect in the nose and\u002For ear that will not be repaired with autologous tissue;\n* Patients who can come to the hospital every week for 6 weeks.\n\nExclusion Criteria:\n\n* Patients with insufficient bone mass for implant placement\n* Patients who cannot come to the hospital for weekly follow-ups\n* Patients that wish an autologous reconstruction\n* Patient is unable to tolerate general anesthesia",true,{"count":20,"type":21},[24],"Facial defects created by trauma, oncological procedures or congenital conditions can be repaired with ear, nose and\u002For eye prostheses. These are fixed on intraosseous implants placed in the temporal, nasal and orbital bone. To date, an osseointegration period of 3-6 months is maintained after which the implants are loaded.\n\nThis study aims to achieve two goals:\n\n1. To load the implants with a nose or ear prosthesis within one month (preferably \\\u003C3 weeks). Patients with an orbital prosthesis will not be recruited. In other words, an optimization of an existing protocol will be investigated. The quality of life of the patients as well as possible complications of the implants will be investigated.\n2. Because of the short time between the surgery and the placement of the prosthesis, the prosthesis will be fabricated remotely. This means that the patient will not have to travel to the prosthetist. The feasibility and aesthetics will be analyzed through questionnaires for the patient.",[32,90],"Implant Complication",[92,93,94,95,96,97,98],"Facial defect","Facial Prosthesis","Ear prosthesis","Nose prosthesis","Craniofacial implant","Anaplastology","Prosthesis fabrication","NOT_YET_RECRUITING","2024-07-16",{"date":102,"type":43},"2024-07-17",{"date":104,"type":21},"2024-09-15",{"date":106,"type":21},"2025-12-31",{"name":108,"class":50},"University Hospital, Ghent"]