💬In plain words
What the trial is, and whether it could suit you
The experience of face and hand composite tissue transplantations reported in the international community have mainly concerned trauma patients. Feasibility and individual benefit have been demonstrated for these indications, in properly selected patients. The first laryngeal transplantation also concerned a case of post-traumatic reconstruction. A certain number of patients, who have suffered direct (extended period of intubation during a stay in the ICU, road traffic accident etc.) or indirect trauma (thermal or chemical burns) to the larynx, present irreversible trauma or injury to the larynx in which conventional treatments are unable to restore laryngeal function. These patients find themselves severely disabled, with a significant reduction in their quality of life. They suffer from stigmatization which leads to social isolation (professional and personal). In some circumstances, p
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Patients presenting with the permanent loss of laryngeal functions. Loss of laryngeal function is considered when a patient is permanently tracheotomized, is mutic and presented failure for each of the three conventional treatment. Conventional treatment lines are organized in the following manner firstly laser, then prosthesis and lastly surgery) Diet may be normal.
* Adults aged between 18 to 60 years;
* ASA (American Society of Anesthesiology) score \< 3 and the health status of the patients must be compatible not only with the graft but also with all the treatments envisaged by the study (according investigator assessment);
* Psychological maturity: recipients should be psychologically balanced, assessed by the team psychiatrists, have taken personality tests, determined and willing, capable of understanding the information provided on the risks relating to the surgery and the immunosuppressive treatment, and capable of making their own decision regarding the transplantation. The psychological preparation for the transplantation requires relationships to be built up prior to the procedure between the patient, the team providing care for laryngectomized patients, the rehabilitation team, the surgical team and the psychiatrist;
* Patients capable of understanding the information provided on the risks relating to the study, and capable of making their own decision regarding the transplantation according investigator assessment;
* Having given written informed consent prior to any procedure related to the study;
* Covered by a Health System where applicable, and/or in compliance with the recommendations of the national laws in force relating to biomedical research.
Exclusion Criteria:
* Minors or patients aged over 60 years;
* Patients with a history of cancer of the upper airways or upper digestive tract; excepted:
* Patients, non-smoker, who have undergone total laryngectomy for squamous cell carcinoma of the larynx, in complete remission for at least 5 years \*. Remission for at least 5 years will be confirmed with imaging, endoscopy or histology.
* Patients with low-grade chondrosarcoma of the larynx, a tumor with very low metastatic potential, often classified as intermediate or even benign (complete resection with histologically confirmed healthy margins)\*
* Patients who are already receiving immunosuppressive treatment (Only patients already receiving an immunosuppressive dose equivalent to that specified in the study protocol may be considered under this criterion)
* Patients with a history of other types of malignancy;
* Patients presenting with a progressive malignant tumor; suspicious laryngeal lesions (dysplasia ...)
* Patients with addiction to alcohol and/or smoking (Consumption of alcohol in the last 5 years and/or consumption of more than 10 packs per year that has not been stopped in the last 5 years).
* Patient presenting hepatitis B, hepatitis C, or HIV(Human Immunodeficiency Virus) infection;
* Patients with a history of psychiatric disorders: known delusional psychosis, untreated severely depressed patients, patients with severe behavioral disorders, patients with permanent generalized anxiety disorder,
* ASA (American Society of Anesthesiology) score ≥ 3;
* Patients presenting moderate renal failure which does not justify renal transplantation with a glomerular filtration rate of less than 60 mL/min per 1.73 m2 calculated using the CKD-EPI formula;
* Arterial hypertension treated by more than one therapy;
* Testing for anti-HLA antibodies will be carried out at the initial inclusion visit, a cross-match will be carried out immediately before transplantation, a positive cross-match will be considered as an automatic contraindication to carrying out the transplantation;
* Women who are pregnant or not taking contraception (effective contraceptive method compulsory);
* Women who are breastfeeding;
* People who have been deprived of their freedom through a legal or administrative decision;
* Adult with a legal guardian;
* Patients in emergency situations;
* EBV (Epstein-Barr Virus) seronegative recipient with EBV seropositive graft, due to the risk of lymphoma.
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