Autologous Muscle Derived Cells for Treatment of Tongue Dysphagia (NCT05421689) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
Autologous Muscle Derived Cells for Treatment of Tongue Dysphagia
United States66 participantsStarted 2022-05-26
Plain-language 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 tongue dysphagia in male and female patients who have undergone surgery and/or chemo- and/or radiotherapy for squamous cell cancer of the oropharynx.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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, 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 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.
✕. 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.
What they're measuring
1
Study product-related, biopsy procedure-related, and injection procedure-related adverse events.
Timeframe: 24 months
2
Anterior tongue pressure measured from Iowa Oral Performance Instrument (IOPI)
✕. 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).