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Transplantation
Larynx Transplant for Post-Laryngectomy
N/A
Waitlist Available
Led By David G Lott
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Low-grade chondrosarcoma requiring total laryngectomy
Potential subjects for this study include patients with severe laryngeal dysfunction or a previous laryngectomy. For the purposes of this study, severe laryngeal dysfunction is defined as the loss of normal laryngeal function resulting in significant dysphonia, dysphagia, or dyspnea.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing whether human laryngeal allograft transplantation is safe and effective.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects aren't specified here but generally may include risks associated with surgery such as infection, rejection of the transplanted organ, complications from anesthesia, bleeding, scarring and the need for lifelong immunosuppressive medications.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a low-grade cancer in my voice box requiring complete removal.
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I have severe voice box issues or have had my voice box removed.
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I am 18 years old or older.
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I have severe voice box issues.
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I have a narrowed voice box.
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I need a total laryngectomy for my laryngeal cancer and am already on immunosuppression.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Survival of the allograft at the one-year visit.
Secondary outcome measures
Ability to have tracheotomy tube decannulated
Pulmonary function
Swallowing without aspiration at the one-year visit.
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Larynx Allograft TransplantationExperimental Treatment1 Intervention
Cadaveric laryngotracheal transplantation
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,206 Previous Clinical Trials
3,767,073 Total Patients Enrolled
David G LottPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I have multiple health issues making a transplant too risky for me.My diabetes is under control with HbA1C below 7.I have a low-grade cancer in my voice box requiring complete removal.You have infections that cannot be controlled or treated.You cannot take part in exercise training before surgery.You have been smoking regularly in the last 6 months.I have severe voice box issues or have had my voice box removed.I was diagnosed with cancer within the last 5 years.I frequently inhale food or liquid into my lungs or have severe acid reflux that can't be controlled.You have a connective tissue disease that is currently active, unless your situation is special and needs to be looked at individually.I am considered high risk due to my mental or social situation.I am 18 years old or older.You have been drinking a lot of alcohol in the past 6 months.I have severe voice box issues.I have a narrowed voice box.It has been over 5 years since my last treatment for head and neck cancer.I need a total laryngectomy for my laryngeal cancer and am already on immunosuppression.My BMI is over 29, but I might still qualify based on my specific situation.My BMI is under 18, indicating I might have cachexia.My kidneys are not working well (low creatinine clearance).I have severe liver problems.I have serious kidney problems.I am not a good candidate for surgery due to my health condition.My cancer is active and not yet cured, but I might be an exceptional case.It has been less than 5 years since I completed my main cancer treatment.I need more than 10 mg/day of steroids and cannot reduce the dose.I have a heart condition that cannot be treated.I have an active neuromuscular condition.You have used drugs or alcohol regularly in the past 6 months.I do not have any other illnesses that would shorten my life.I am either male or female.
Research Study Groups:
This trial has the following groups:- Group 1: Larynx Allograft Transplantation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any openings available for participants of this clinical trial?
"Unfortunately, the information available on clinicaltrials.gov suggests that this medical study is not currently recruiting. The initial posting date was May 1st 2022 and it has been updated as recently as June 14th 2022. Thankfully, there are 15 other trials actively looking for participants at present."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic in Arizona
What portion of applicants met pre-screening criteria?
Did not meet criteria
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