Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) for Tongue Dysphagia

Inclusion Criteria:

1. Male or Female, at least 18 years old, with primary symptoms of TD following surgeryand/or chemo- and/or radiotherapy for treatment of squamous cell carcinoma fororopharyngeal cancer. Treatment must be completed at least 24 months prior toenrollment, with TD and disease-free status confirmed by medical history andclinical symptoms, including a focused head and neck examination evaluation,swallowing fluoroscopy, and high resolution pharyngeal manometry.

2. 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.

3. Patient has failed to achieve acceptable resolution of symptoms followingconservative therapies.

Exclusion Criteria:

Patient History-based Criteria:

1. Simultaneously participating in another investigational drug or device study or hascompleted the follow-up phase for the primary endpoint of any previous study lessthan 30 days prior to the first evaluation in this study.

2. Previously treated with an investigational device, drug, or procedure for TD within 6 months prior to signing consent.

3. Has ever been treated with a cell therapy for TD.

4. Symptoms of aspiration pneumonia prior to enrollment.

5. TD of neurogenic etiology or uncorrected congenital abnormality leading to TD.

6. Neuromuscular disorder (e.g., Parkinson's disease, muscular dystrophy, multiplesclerosis) that could lead to TD.

7. Moderate or severe fibrosis at likely injection site.

8. Morbidly obese (BMI ≥ 35).

9. Uncontrolled diabetes.

10. Compromised immune system due to disease state, chronic corticosteroid use, or otherimmunosuppressive therapy.

11. Medical condition or disorder that may limit life expectancy or that may causeclinical investigation plan (CIP) deviations (e.g., unable to performself-evaluations or accurately report medical history, symptoms, or data).

12. History of bleeding diathesis or uncorrectable coagulopathy.

13. Known allergy or hypersensitivity to bovine proteins or allergens, gentamicinsulfate, or ampicillin that medically warrants exclusion as determined by thephysician.

14. Any non-skin cancer that has necessitated treatment within the past 24 months.

Patient's Current Status-based Criteria:

1. Evidence or known high risk of recurrent or persistent cancer as determined by thephysician during screening.

2. 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. a. Tests performed by certified/authorized testing laboratory usinglicensed/approved tests and performed on blood samples collected within 30 daysprior to muscle tissue procurement.

3. Cannot, or is not willing to, maintain the current treatment regimen for existingconservative therapy (e.g., swallowing therapy).

4. Requires prophylactic antibiotics for chronic infections, or has required 2 or morecourses of antibiotics for infections in the 2 months prior to signing consent.

5. Any condition, including current infection, which could lead to significantpostoperative complications.

6. Refuses to provide written informed consent.

7. Not available for, or willing to comply, with the baseline and follow-up evaluationsas required by the CIP.

8. Pregnant, lactating, or plans to become pregnant during the course of the study.