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Autologous Muscle Derived Cells for Swallowing Disorders
Study Summary
This trial is testing a new drug to see if it is safe for people who have had surgery, chemo, or radiotherapy for tongue cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- My doctor says my cancer is likely to come back or not go away.I do not have a bleeding disorder that cannot be corrected.I have a condition that could cause serious problems after surgery.I haven't had experimental treatments for TD in the last 6 months.I have been treated for a non-skin cancer within the last 2 years.I have severe scarring where I've been injected before.My swallowing difficulty is moderate, and I can eat some or most foods.My diabetes is not under control.I finished my treatment 2 years ago and have been disease-free since, confirmed by tests and doctor's exams.I need antibiotics regularly to prevent infections or have needed them multiple times recently.I am 18 or older with throat dryness from treatment for throat cancer.I have a condition like Parkinson's, muscular dystrophy, or MS.My immune system is weak due to a condition, steroid use, or other treatments.My TD is due to nerve damage or a birth defect that hasn't been fixed.I cannot or do not want to continue my current therapy, like swallowing therapy.My symptoms did not improve after trying current treatments.
- Group 1: Experimental: 150 x 10⁶ AMDC-GIR dosage
- Group 2: Experimental: Identical Placebo composed of the same cryopreservation medium used for AMDC-GIR
- 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
Is this clinical trial actively searching for participants?
"Affirmative. According to clinicaltrials.gov, the trial which was first shared on May 26th 2022 is still recruiting participants. 62 people are needed for 2 designated medical centres."
How many individuals have been recruited for the clinical trial thus far?
"Correct. Per the information published on clinicaltrials.gov, this medical experiment is actively looking for individuals to take part in it; the trial was first advertised on May 26th 2022 and most recently updated on June 13th 2022. The study needs 62 participants from 2 sites."
What is the central goal of this experiment?
"According to the study sponsor, Cook MyoSite, this 24-month trial will mainly evaluate Anterior tongue pressure using Iowa Oral Performance Instrument (IOPI). Furthermore, there are secondary objectives such as assessing patients' survival rate and incidence of aspiration pneumonia alongside dysphagia symptoms evaluated through Eating Assessment Tool EAT10. This 10 question survey ranges from 0-4 scoring criteria where 0 indicates no issue and 4 marks a severe problem."
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