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Cell Therapy

Cell Therapy for Swallowing Disorders

Phase 1
Recruiting
Led By Peter Belafsky, MD, PhD
Research Sponsored by Peter Belafsky, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
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.
Must not have
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.
Previously treated with an investigational device, drug, or procedure for TD within 6 months prior to signing consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a new treatment for tongue dysphagia caused by squamous cell cancer. The treatment involves injecting cells from the patient's own muscles into the tongue. The trial will evaluate the safety of this treatment over 12 months.

Who is the study for?
This trial is for adults who have moderate tongue dysphagia after treatment for oropharyngeal cancer and haven't improved with standard therapies. They must be at least 2 years post-treatment, disease-free, and able to report medical history. Excluded are those with recent participation in other trials, cell therapy for TD, certain health conditions like severe fibrosis or obesity, uncontrolled diabetes, bleeding disorders, allergies to specific drugs or proteins used in the study.
What is being tested?
The trial tests the safety of AMDC-GIR cells injected into patients' tongues to treat swallowing difficulties over a year. Participants have had surgery/chemo/radiotherapy for squamous cell carcinoma but still struggle with swallowing (tongue dysphagia) despite conventional treatments.
What are the potential side effects?
Potential side effects may include reactions at the injection site such as pain or swelling, risk of infection due to injections, allergic responses if sensitive to bovine proteins or related antibiotics used during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can eat solid foods without special preparation.
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I am over 18, had treatment for throat cancer over 2 years ago, and have trouble swallowing without cancer returning.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I need antibiotics regularly to prevent infections or have needed multiple antibiotic treatments recently.
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I have not been part of a trial for TD treatment in the last 6 months.
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I have moderate to severe scarring where injections are usually given.
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My diabetes is not under control.
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My immune system is weak due to my condition, medication, or other treatments.
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My BMI is 35 or higher.
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I have had symptoms of aspiration pneumonia before joining.
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I have received cell therapy for TD.
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I have a bleeding disorder that cannot be corrected.
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My TD is caused by nerve issues or a birth defect that hasn't been fixed.
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I have a condition like Parkinson's, muscular dystrophy, or MS.
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I have a condition that could cause serious problems after surgery.
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I am allergic to bovine proteins, gentamicin sulfate, or ampicillin.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Study product-related Serious Adverse Events (SAEs)
Study product-related, biopsy procedure-related, and injection procedure-related adverse events
Secondary study objectives
Anterior tongue pressure measurement from Iowa Oral Performance Instrument (IOPI)
Patient-reported dysphagia symptoms based on Eating Assessment Tool- EAT10 score
Patient-reported quality of life based on SF-12 survey score
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: 300 x 106 dosageExperimental Treatment1 Intervention
10 subjects will be receiving a dosage of 300 x 106 AMDC-GIR
Group II: 150 x 106 dosageExperimental Treatment1 Intervention
10 subjects will be receiving a dosage of 150 x 106 AMDC-GIR

Find a Location

Who is running the clinical trial?

Peter Belafsky, MDLead Sponsor
1 Previous Clinical Trials
1 Total Patients Enrolled
Cook MyoSiteIndustry Sponsor
12 Previous Clinical Trials
988 Total Patients Enrolled
Peter Belafsky, MD, PhDPrincipal Investigator - University of California Davis, Department of Otolaryngology
Shriners Hospitals for Children-Northern California, University of California-Davis Medical Center
Tulane University School Of Medicine (Medical School)
Tulane University School Of Medicine (Residency)
4 Previous Clinical Trials
7 Total Patients Enrolled

Media Library

Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) (Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02838316 — Phase 1
Oropharyngeal Dysphagia Research Study Groups: 150 x 106 dosage, 300 x 106 dosage
Oropharyngeal Dysphagia Clinical Trial 2023: Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) Highlights & Side Effects. Trial Name: NCT02838316 — Phase 1
Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) (Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02838316 — Phase 1
~4 spots leftby Dec 2026
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