[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"craniofacial-defects\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:craniofacial-defects":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":5},"100586027","long-term-safety-and-performance-of-cmf-porous-titanium-implants-100586027",false,"NCT06910033","Long-term Safety and Performance of CMF Porous Titanium Implants","CMF SafeTi Fit: Long-term Safety and Performance of CMF Porous Titanium Implants","CMF SafeTi Fit","Inclusion Criteria:\n\n* Age: Patients of any age are eligible for this study.\n* Patients treated with Materialise patient-specific CMF Porous Titanium Implants for facial and\u002For cranial reconstruction.\n* Patients who have followed Standard of Care, as determined in each case by the treating surgeon.\n\nExclusion Criteria:\n\n* Known hypersensitivity to Titanium at the time of surgery.\n* Patients who had or will receive the TMJ Total Arthroplasty System.\n* Pregnancy at the time of surgery.","ALL",{"count":19,"type":20},200,"ESTIMATED","OBSERVATIONAL","The goal of this retrospective study is to evaluate the clinical characteristics, efficiency, safety, and long-term performance of craniomaxillofacial (CMF) Porous Titanium Implants within the standard of care across children (0 - \\\u003C12 years old), adolescent (12 - \\\u003C22 years old), and adult (≥ 22 years old) populations.",[24],"Craniofacial Defects",[24,26],"Implants","NOT_YET_RECRUITING","2025-09-26",{"date":30,"type":31},"2025-09-29","ACTUAL",{"date":33,"type":20},"2025-11",{"date":35,"type":20},"2026-11",{"name":37,"class":38},"Materialise","INDUSTRY",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":43,"acronym":4,"eligibilityCriteria":44,"healthyVolunteers":11,"sex":17,"minAge":45,"maxAge":46,"enrollmentInfo":47,"targetDuration":4,"studyType":49,"phases":50,"briefSummary":52,"conditions":53,"keywords":59,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"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.","18 Years","65 Years",{"count":48,"type":20},15,"INTERVENTIONAL",[51],"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.",[54,55,56,24,57,58],"Facial Injuries","Traumatic Wounds and Injuries","Craniofacial Injuries","Facial Transplantation","Facial Deformity",[54,60,57,58],"Face Transplant","RECRUITING","2025-08-11",{"date":64,"type":31},"2025-08-14",{"date":66,"type":31},"2012-08",{"date":68,"type":20},"2031-08",{"name":70,"class":71},"Johns Hopkins University","OTHER",1]