Status:
ACTIVE_NOT_RECRUITING
Autologous Muscle Derived Cells for Treatment of Tongue Dysphagia
Lead Sponsor:
University of California, Davis
Collaborating Sponsors:
California Institute for Regenerative Medicine (CIRM)
Cook MyoSite
Conditions:
Oropharyngeal Dysphagia
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
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 ...
Detailed Description
The purpose of this double-blind, randomized, placebo-controlled, multicenter clinical trial is to evaluate the safety and efficacy of Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMD...
Eligibility Criteria
Inclusion
- 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.
- 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.
- Patient has failed to achieve resolution of symptoms following contemporary therapies.
Exclusion
- 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.
- 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.
- Severe fibrosis at injection site.
- 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 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 contemporary therapy (e.g., swallowing therapy).
- 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.
- 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 during the course of the study.
Key Trial Info
Start Date :
May 26 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT05421689
Start Date
May 26 2022
End Date
December 31 2026
Last Update
December 12 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
UC Davis Medical Center, Department of Otolaryngology
Sacramento, California, United States, 95817
2
UC San Francisco Medical Center, Voice and Swallow Center
San Francisco, California, United States, 94115