Evaluation of laryngeal transplantation in patients with severe laryngeal damage

Clinical Evaluation of Laryngeal Transplantation: Pilot Study of 3 Patients

This study is testing if laryngeal transplantation can help people with severe laryngeal damage regain their ability to speak and swallow, improving their quality of life.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 3 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Hospices Civils de Lyon (Academic / other)
• Locations: 3 sites (Lyon and 2 other locations)
• Trial ID: NCT02821299 on ClinicalTrials.gov

What this trial studies

This clinical evaluation focuses on the feasibility and outcomes of laryngeal transplantation in patients who have suffered irreversible laryngeal damage due to trauma or other causes. The study aims to assess the restoration of laryngeal function, including voice production and swallowing, in individuals who have not benefited from conventional treatments. By transplanting healthy laryngeal tissue, the study seeks to improve the quality of life for these patients, who often experience significant social isolation and disability. The trial will involve a small cohort of three patients, allowing for detailed observation of the surgical and functional outcomes.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 60 with permanent loss of laryngeal function who have failed conventional treatment options.

Not a fit: Patients who do not have permanent laryngeal damage or those who are not psychologically prepared for the surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this procedure could significantly improve voice and swallowing functions for patients with severe laryngeal injuries.

How similar studies have performed: While laryngeal transplantation is a novel approach, similar composite tissue transplants have shown success in other areas, indicating potential for positive outcomes.

Eligibility criteria

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.

Where this trial is running

Lyon and 2 other locations

• Service d'Urologie et Chirurgie de la Transplantation - Hôpital Edouard Herriot - Hospices Civils de Lyon — Lyon, France (Recruiting)
• Service ORL & Chirurgie Cervicofaciale - Hôpital Charles Nicolle - CHU Rouen — Rouen, France (Recruiting)
• Centre de soins de suite et de réadaptation fonctionnelle - SSR Val Rosay — Saint-Didier-au-Mont-d'Or, France (Recruiting)

Study contacts

• Study coordinator: Lionel BADET, MD

Conditions Laryngeal Transplantation; Laryngeal transplantation; Laryngeal function; Swallowing; Voice production; Respiration; Quality of life