This clinical trial is being held at two sites, UC Davis and UCSF. For the UC Davis site Dr. Peter Belafsky is the site PI, and for the UCSF site Dr. Clark Rosen is the site PI. This study will take muscle cells from your leg, process them in a special manner and then use them as a treatment for swallowing problems related to injury to the tongue from cancer (tongue or tonsil) treatment.
This is a double blind, placebo-controlled Phase II clinical trial. Subjects that received placebo treatment will be offered the stem cell tongue injections after they completed their primary 24 month study.
This study requires
Participants must be committed to completing the study which involves 8 in-office visits and 7 virtual visits over the course of 26 months, at either UC Davis or UCSF.
Participants will have a muscle biopsy taken from their thigh. Our partner, MyoSite, will extract your stem cells from the biopsy. Your muscle stem cells will then be injected into your tongue, on two separate clinic visits, spaced 4-6 weeks apart.
Patients given placebo will all be offered the opportunity for muscle stem cell treatment after they are unblinded, 24-months after the initial treatment.
Who can participate
• 18 years of age or older • Moderate swallowing difficulties after receiving treatment for head and neck cancer • You cannot have had any cancer treatments within 24 months (with the exception of skin cancer). • You must have a consistent level of eating/drinking by mouth (some tube feeding is OK). • You cannot have a neuromuscular disorder (e.g. Parkinson's Disease, Muscular Dystrophy, multiple sclerosis). • You cannot have a medical condition that requires chronic use of steroids or other immunosuppressive therapy. • You cannot have chronic infections that require multiple courses of antibiotics within 2 months of signing consent. • You cannot be pregnant, lactating, or have plans on becoming pregnant during the course of the study. • You cannot have uncontrolled diabetes. • If taking blood thinner medication (e.g. Aspirin, Eliquis) you must be able to pause its use for 10 days prior to study procedures. • You cannot have active Hepatitis, HIV, or Syphilis. • Willing to travel to either UC Davis or UCSF for trial.
Benefits and risks of participating
Some patients will receive placebo. However, patients given placebo will all be offered the opportunity for muscle stem cell treatment at the end of the study. Patients must be willing to travel to either UC Davis or UCSF for this clinical trial.
Patients are not compensated for their participation in this study. However, travel vouchers are available.
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