Larynx Transplant for Post-Laryngectomy

Not currently recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must be taking: Immunosuppressants

Disqualifiers: Pregnancy, Cancer, Obesity, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a larynx transplant (larynx allograft transplantation) to assist individuals who have lost their voice box or experience difficulties speaking, swallowing, or breathing. The goal is to determine if this transplant can safely and effectively restore these functions. Suitable candidates include those who have had their voice box removed or face severe larynx issues, such as difficulty speaking or breathing. As an unphased trial, this study provides a unique opportunity for patients to contribute to groundbreaking research that could significantly enhance quality of life.

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 prior data suggests that larynx allograft transplantation is safe?

Research shows that larynx transplants, which replace the voice box, offer a promising option for those who have lost theirs. However, safety concerns remain. In previous studies, some patients experienced serious complications after receiving the transplant. For example, after two years, 27% of patients had died, and some required removal of the transplanted voice box. While the procedure may offer benefits, understanding these risks is crucial. Prospective trial participants should discuss these points with their doctor. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Larynx allograft transplantation is unique because it offers the possibility of restoring a natural voice and breathing function for individuals who have undergone a laryngectomy, unlike current options like artificial voice prostheses or tracheoesophageal puncture, which can be limiting. Researchers are excited about this treatment because it involves transplanting a larynx from a donor, which could potentially restore normal speech and airway functions in a way that current prosthetic solutions cannot. This approach is groundbreaking, as it aims to address not only the physical aspects but also the quality of life factors for patients, offering a more holistic solution.

What evidence suggests that larynx allograft transplantation might be an effective treatment for severe laryngeal incompetence?

Research shows that a larynx transplant can help people speak and swallow again after their voice box is removed. Some studies have shown good results, with patients regaining these abilities, although breathing without assistance remains difficult. In some cases, patients experienced no major problems, but the new voice box didn't always function as expected. Experts believe this treatment could greatly improve life for those with serious voice box issues. Despite some challenges, the chance to speak and swallow again offers hope for patients. ^{1 2 3 6 7}

Who Is on the Research Team?

David G Lott, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

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.

I have severe voice box issues or have had my voice box removed.

Ability to obtain informed consent from the patient

Exclusion Criteria

You have severe intellectual disability, severe mental illness, or significant brain damage.

You have a condition that weakens your immune system, unless exceptions are made after reviewing your specific situation.

I cannot walk more than 600 feet in 6 minutes.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Larynx Allograft Transplantation Experimental Treatment 1 Intervention

Cadaveric laryngotracheal transplantation

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12267005/

What are the functional outcomes of total laryngeal ... Laryngeal transplantation shows promising results in restoring swallowing and phonation, but challenges remain for breathing without ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1879729623001679

Laryngeal graft after total laryngectomy in humans: A SWiM ... There were no reported complications or perioperative problems. In 3 patients, the larynx remained immobile. In terms of phonation, in the first 3 patients ...

3. withpower.com withpower.com/trial/larynx-transplant-for-post-laryngectomy-84da9

Larynx Transplant for Post-Laryngectomy 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 ...

4. mayoclinic.org mayoclinic.org/departments-centers/larynx-trachea-transplant/overview/ovc-20508897

Larynx and Trachea Transplant Program - Overview Larynx transplant is a promising option to restore quality-of-life in people with severe laryngeal dysfunction or a laryngectomy. Our program.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2884843/

Laryngeal Transplantation: Research, Clinical Experience ... The possibility of reversing the negative functional and aesthetic effects of laryngectomy has encouraged a significant percentage of postlaryngectomy patients ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0025619624003227

Total Laryngeal Transplant in the Setting of Active ... Laryngeal transplant (LT) is a promising option to restore quality of life in patients with severe laryngeal dysfunction or a laryngectomy.

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1002/lary.31551

The Global Experience of Laryngeal Transplantation ... Results. After a minimum of 24 months follow-up, three patients had died (27%), and there were two graft explants in survivors, one ...