Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) for Tongue Dysphagia (NCT02838316) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) for Tongue Dysphagia
United States18 participantsStarted 2017-05-24
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
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 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
✕. 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.
✕
What they're measuring
1
Study product-related Serious Adverse Events (SAEs)
Timeframe: 24 months
2
Study product-related, biopsy procedure-related, and injection procedure-related adverse events