A Multi-Center, Double-Blind, Randomized Placebo-Controlled Investigation of Autologous Muscle Derived Cells (AMDC) for the Treatment of Tongue Dysphagia Resulting From the Treatment of Head and Neck Cancer

1800521

The primary objective of this double-blind, randomized, placebo-controlled, multicenter clinical trial is to evaluate the safety of AMDC-GIR during the 24 months following 2 consecutive treatments of tongue dysphagia in male and female patients who have undergone surgery and/or chemo- and/or radiotherapy for squamous cell cancer of the oropharynx.

2022-05-26

2026-01-31

2026-01-31

Recruiting

Early phase I

62

Inclusion Criteria: 1. 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. 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 and EAT-10 score of greater than 5. 3. Patient has failed to achieve resolution of symptoms following contemporary therapies. Exclusion Criteria: 1. 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. 2. Previously treated with an investigational device, drug, or procedure for TD within 6 months prior to signing consent. 3. TD of neurogenic etiology or uncorrected congenital abnormality leading to TD. 4. Neuromuscular disorder (e.g., Parkinson's disease, muscular dystrophy, multiple sclerosis) that could lead to TD. 5. Severe fibrosis at injection site. 6. Uncontrolled diabetes. 7. Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy. 8. 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). 9. History of bleeding diathesis or uncorrectable coagulopathy. 10. Known allergy or hypersensitivity to bovine proteins or allergens, gentamicin sulfate, or ampicillin that medically warrants exclusion as determined by the physician. 11. 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 the physician 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 using licensed/approved tests and performed on blood samples collected within 30 days prior to muscle tissue procurement. 3. Cannot, or is not willing to maintain the current treatment regimen for existing contemporary therapy (e.g., swallowing therapy). 4. 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. 5. Any condition, including current infection or immunodeficiency, which could lead to significant postoperative complications. 6. Refuses or cannot provide written informed consent. 7. Not available for, or willing to comply with the baseline and follow-up evaluations as required by the CIP. 8. Pregnant, lactating, or plans to become pregnant during the course of the study.

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2024-05-16