10 Participants Needed

Larynx Transplant for Post-Laryngectomy

Recruiting at 1 trial location
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Mayo Clinic
Must be taking: Immunosuppressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

DG

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

I have a low-grade cancer in my voice box requiring complete removal.
Ability to obtain informed consent from the patient
I have severe voice box issues or have had my voice box removed.
See 5 more

Exclusion Criteria

You have severe intellectual disability, severe mental illness, or significant brain damage.
I cannot walk more than 600 feet in 6 minutes.
You have a condition that weakens your immune system, unless exceptions are made after reviewing your specific situation.
See 25 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplantation and Initial Recovery

Patients undergo cadaveric laryngotracheal transplantation and initial recovery, including monitoring for short-term complications and hospital stay

4-6 weeks

Follow-up

Participants are monitored for survival of the allograft, voice evaluation, pulmonary function, and ability to have tracheotomy tube decannulated

1 year

Treatment Details

Interventions

  • Larynx Allograft Transplantation
Trial Overview The study tests the safety and effectiveness of transplanting a donor's larynx (voice box) into patients with serious voice box problems or damage. This could help people speak, swallow, or breathe better when other treatments haven't worked.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Larynx Allograft TransplantationExperimental Treatment1 Intervention
Cadaveric laryngotracheal transplantation

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

References

Management of larynx and trachea donors. [2007]
Laryngeal Transplantation. [2021]
Laryngeal nerve function after total laryngeal transplantation. [2006]
Laryngeal Transplantation. [2020]
The current status of human laryngeal transplantation in 2017: A state of the field review. [2022]
[Establishment of a modified larynx transplantation model with inbred F344 rat]. [2015]
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