Autologous Muscle Derived Cells for Treatment of Tongue Dysphagia

Prior treatment

• Simultaneously participating in another investigational drug or device study or has completed the follow-up phase for the primary endpoint of any previous study less than 30 days prior to the first evaluation in this study.
• Previously treated with an investigational device, drug, or procedure for TD within 6 months prior to signing consent.
• Cannot, or is not willing to maintain the current treatment regimen for existing contemporary therapy (e.g., swallowing therapy).
• Requires prophylactic antibiotics for chronic infection or has required 2 or more courses of antibiotics for infections in the 2 months prior to signing consent.

Other illness

• Neuromuscular disorder (e.g., Parkinson's disease, muscular dystrophy, multiple sclerosis) that could lead to TD.
• Uncontrolled diabetes.
• Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy.
• Medical condition or disorder that may limit life expectancy or that may cause CIP deviations (e.g., unable to perform self-evaluations or accurately report medical history, symptoms, or data).
• History of bleeding diathesis or uncorrectable coagulopathy.
• Known allergy or hypersensitivity to bovine proteins or allergens, gentamicin sulfate, or ampicillin that medically warrants exclusion as determined by the physician.
• Any non-skin cancer that has necessitated treatment within the past 24 months.
  • Patient's Current Status-based Criteria:
• Evidence or known high risk of recurrent or persistent cancer as determined by the physician during screening.
• Any condition, including current infection or immunodeficiency, which could lead to significant postoperative complications.

Lab values

• Tests positive for Hepatitis B (required tests: Hepatitis B Surface Antigen \[HBsAg\] and Anti-Hepatitis B Core Antibody \[Anti-HBc\]), Hepatitis C (required test: Hepatitis C Antibody \[Anti-HCV\]), HIV (required tests: HIV Type 1 and 2 Antibodies \[Anti-HIV-1, 2\]), and/or Syphilis.
  • Tests performed by certified/authorized testing laboratory using licensed/approved tests and performed on blood samples collected within 30 days prior to muscle tissue procurement.

Other

• TD of neurogenic etiology or uncorrected congenital abnormality leading to TD.
• Severe fibrosis at injection site.
• Refuses or cannot provide written informed consent.
• Not available for, or willing to comply with the baseline and follow-up evaluations as required by the CIP.
• Pregnant, lactating, or plans to become pregnant during the course of the study.

• Male or Female, at least 18 years old, with primary symptoms of TD following surgery and/or chemo- and/or radiotherapy for treatment of squamous cell carcinoma for oropharyngeal cancer. Treatment must be completed at least 24 months prior to enrollment, with TD and disease-free status confirmed by medical history, clinical symptoms, a focused head and neck examination, swallowing fluoroscopy, and high-resolution pharyngeal manometry.
• TD severity should be moderate as defined by a Functional Oral Intake Scale (FOIS, provided in Appendix C). Individuals must have a FOIS of 3 or better and EAT-10 score of greater than 5.
• Patient has failed to achieve resolution of symptoms following contemporary therapies.