Pilot Study of Laryngeal Transplantation for Adults Aged 18 to 60 Evaluating Treatment Outcomes for Permanent Loss of Laryngeal Function

What this Trial Is About

Researchers are evaluating laryngeal transplantation in adults aged 18 to 60 who have lost permanent laryngeal function due to trauma or injury not treatable by conventional methods. This study focuses on patients who are severely disabled and face social isolation from their impaired ability to speak, breathe, and swallow. The trial aims to analyze three patients receiving this transplant to determine whether it improves function and quality of life when other surgeries have failed. The treatment involves laryngeal transplantation using a specific nerve re-innervation technique designed to improve functional outcomes and enable patients to be decannulated. A dual immunosuppressive therapy regimen will be applied and adjusted based on the patients condition and the type of tissue transplanted. This pilot study will observe three patients receiving this procedure, with each patient serving as their own control for before-and-after comparisons. Participants will be assessed over three years after transplantation through measures including swallowing ability using the Deglutition Handicap Index, voice quality by patient questionnaires, breathing evaluated by decannulation status, and graft survival. Psychological evaluations, informed consent, and health status assessments are part of participant involvement. The study includes long-term monitoring of functional outcomes and graft viability to better understand the benefits and challenges of this novel transplant approach.

Clinical Evaluation of Laryngeal Transplantation: Study of 3 Patients