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

Running, not enrolling · Phase 1

Conditions studied: Oropharyngeal Dysphagia

In brief

The primary objective of this study is to evaluate the safety of Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) during the 12 months following treatment 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.

Key facts

Study ID

NCT02838316

Run by

Peter Belafsky, MD

People needed

18

Starts

2017-05-24

Expected to finish

2026-12-01

Last updated by the study team

2026-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UC Davis Medical Center, Department of Otolaryngology, Head and Neck Surgery — Sacramento, California, United States

Full record on ClinicalTrials.gov

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