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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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I can eat solid foods without special preparation.
Select...
I am over 18, had treatment for throat cancer over 2 years ago, and have trouble swallowing without cancer returning.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Study product-related Serious Adverse Events (SAEs)
Study product-related, biopsy procedure-related, and injection procedure-related adverse events
Secondary outcome measures
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 moreTrial 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
1,012 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I need antibiotics regularly to prevent infections or have needed multiple antibiotic treatments recently.I have not been part of a trial for TD treatment in the last 6 months.I have moderate to severe scarring where injections are usually given.My diabetes is not under control.My immune system is weak due to my condition, medication, or other treatments.I have been treated for a non-skin cancer within the last 2 years.My doctor thinks my cancer is likely to come back or not go away.I have tested positive for Hepatitis B, C, HIV, or Syphilis recently.I cannot or do not want to continue my current non-surgical treatment.I can eat solid foods without special preparation.My BMI is 35 or higher.My symptoms did not improve after trying standard treatments.I have had symptoms of aspiration pneumonia before joining.I am over 18, had treatment for throat cancer over 2 years ago, and have trouble swallowing without cancer returning.I have received cell therapy for TD.I have a bleeding disorder that cannot be corrected.My TD is caused by nerve issues or a birth defect that hasn't been fixed.I have a condition like Parkinson's, muscular dystrophy, or MS.I have a condition that could cause serious problems after surgery.I am allergic to bovine proteins, gentamicin sulfate, or ampicillin.
Research Study Groups:
This trial has the following groups:- Group 1: 150 x 106 dosage
- Group 2: 300 x 106 dosage
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new participants being taken for this experiment at the present time?
"According to clinicaltrials.gov, this experiment is currently in the process of recruiting participants with the trial being initially posted on May 24th 2017 and last edited on July 6th 2022."
Answered by AI
Have Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) been given the stamp of approval from the FDA?
"Given the lack of evidence for safety and efficacy, our team allocated Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) a score of 1."
Answered by AI
What is the aggregate amount of participants enrolled in this clinical research?
"Indeed, the trial is actively seeking participants. The initial listing was published on May 24th 2017 and updated as recently as July 6th 2022. A single clinical site requires 20 individuals to be enrolled for the study's completion."
Answered by AI
What results are expected to be generated from this clinical investigation?
"This medical trial will take two years to complete and its primary measure is the incidence of Serious Adverse Events. As secondary outcomes, researchers are recording Pharyngeal Constriction Ratio scores from fluoroscopy testing, Penetration-Aspiration scale ratings also obtained through fluoroscopy imaging, as well as patient reports on dysphagia symptoms gathered with Eating Assessment Tool- EAT10 scorecards."
Answered by AI
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