Larynx Transplant for Post-Laryngectomy
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, you must be able to be weaned to 10 mg/day or less of steroids, which suggests some medication adjustments might be necessary.
What data supports the effectiveness of the larynx transplant treatment for post-laryngectomy patients?
Laryngeal transplantation has been successfully performed in a few cases, showing potential to restore voice and laryngeal function in patients who have lost their larynx due to injury or cancer. Although only two complete transplants have been successful, these cases suggest that the procedure can improve quality of life by enabling normal breathing, swallowing, and voice production.12345
How is larynx allograft transplantation different from other treatments for post-laryngectomy?
Larynx allograft transplantation is unique because it involves transplanting a larynx from a deceased donor to a living recipient, aiming to restore natural breathing, swallowing, and voice production. Unlike other treatments, it requires lifelong use of immunosuppressive drugs to prevent the body from rejecting the transplanted larynx, which raises ethical concerns since the larynx is not a vital organ.13456
What is the purpose of this trial?
The purpose of this proposed study is to obtain safety and efficacy data on human laryngeal allograft transplantation in an effort to safely use these procedures as a viable reconstructive option for patients with severe laryngeal or laryngotracheal incompetence.
Research Team
David G Lott, MD
Principal Investigator
Mayo Clinic
Eligibility Criteria
This trial is for adults over 18 who've been cancer-free for at least 5 years after head and neck cancer treatment. It's suitable for those with severe laryngeal dysfunction or needing a total laryngectomy while already on immunosuppression. Candidates must be able to consent and participate in pre-op training but can't join if they have recent substance abuse, uncontrolled diseases, obesity, or are pregnant.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Transplantation and Initial Recovery
Patients undergo cadaveric laryngotracheal transplantation and initial recovery, including monitoring for short-term complications and hospital stay
Follow-up
Participants are monitored for survival of the allograft, voice evaluation, pulmonary function, and ability to have tracheotomy tube decannulated
Treatment Details
Interventions
- Larynx Allograft Transplantation
Find a Clinic Near You
Who Is Running the Clinical Trial?
Mayo Clinic
Lead Sponsor