Investigation of Autologous Muscle Derived Cells for the Treatment of Tongue Dysphagia Resulting from the Treatment of Head and Neck Cancer, REVIVE Study

Inclusion Criteria

• Male or female, at least 18 years old
• Primary symptoms of TD following surgery and/or chemotherapy and/or radiotherapy for treatment of squamous cell carcinoma for oropharyngeal cancer or unknown primary. 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
• Tongue dysphagia severity should be moderate as defined by a Functional Oral Intake Scale (FOIS). Individuals must have a FOIS level of 3 or better and Eating Assessment Tool (EAT) -10 score of greater than 5
• Participant has failed to achieve resolution of symptoms following contemporary therapies

Exclusion Criteria

• 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
• Has ever been treated with a cell therapy for TD
• Tongue dysphagia of neurogenic etiology or uncorrected congenital abnormality leading to TD
• Neuromuscular disorder (e.g., Parkinson’s disease, muscular dystrophy, multiple sclerosis) that could lead to TD
• Severe fibrosis at injection site
• Anatomy precluding successful needle biopsy of the thigh or injection of investigational product
• 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 clinical investigational plan (CIP) deviations (e.g., unable to perform self-evaluations or accurately report medical history, symptoms, or data)
• History of bleeding diathesis, uncorrectable coagulopathy, inability to titrate anticoagulant medications for study procedures, or would refuse a blood transfusion
• 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
• Evidence or known high risk of recurrent or persistent cancer as determined by the physician during screening
• 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]), human immunodeficiency virus (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
• Cannot or is not willing to maintain the current treatment regimen for existing contemporary therapy (e.g., swallowing therapy)
• Any condition, including current infection or immunodeficiency, which could lead to significant postoperative complications
• 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 while enrolled on the study
• Any condition that in the opinion of the investigator would interfere with the participant’s safety or compliance while on study