Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) for Tongue Dysphagia
Oropharyngeal Dysphagia
About this trial
This is an interventional treatment trial for Oropharyngeal Dysphagia
Eligibility Criteria
Inclusion Criteria:
- 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 and clinical symptoms, including a focused head and neck examination evaluation, 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.
- Patient has failed to achieve acceptable resolution of symptoms following conservative therapies.
Exclusion Criteria:
Patient History-based 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.
- Symptoms of aspiration pneumonia prior to enrollment.
- TD 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.
- Moderate or severe fibrosis at likely injection site.
- Morbidly obese (BMI ≥ 35).
- 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 investigation plan (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.
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.
- Cannot, or is not willing to, maintain the current treatment regimen for existing conservative therapy (e.g., swallowing therapy).
- Requires prophylactic antibiotics for chronic infections, or has required 2 or more courses of antibiotics for infections in the 2 months prior to signing consent.
- Any condition, including current infection, which could lead to significant postoperative complications.
- Refuses to 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.
Sites / Locations
- UC Davis Medical Center, Department of Otolaryngology, Head and Neck SurgeryRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
150 x 106 dosage
300 x 106 dosage
10 subjects will be receiving a dosage of 150 x 106 AMDC-GIR
10 subjects will be receiving a dosage of 300 x 106 AMDC-GIR