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Stem Cell Therapy

Autologous Muscle Derived Cells for Swallowing Disorders

Phase 1 & 2
Recruiting
Led By Peter Belafsky, MD
Research Sponsored by University of California, Davis
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 and EAT-10 score of greater than 5
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe for people who have had surgery, chemo, or radiotherapy for tongue cancer.

Who is the study for?
This trial is for adults who have trouble swallowing (tongue dysphagia) after treatment for oropharyngeal cancer. They must be at least 18, finished with cancer treatment for over two years, and not responding to current therapies. People can't join if they've had recent other trials, uncontrolled diabetes, immune issues, certain allergies, active cancers besides skin cancer, or are pregnant.Check my eligibility
What is being tested?
The study tests the safety of injecting one's own muscle cells (AMDC-GIR) into the tongue versus a placebo in improving swallowing difficulties. Participants will receive two treatments and be monitored over 24 months in this double-blind study where neither they nor the researchers know who gets which treatment.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical risks may include reactions at injection sites like pain or swelling, potential allergic reactions to components used during cell processing or risk of infection post-procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My swallowing difficulty is moderate, and I can eat some or most foods.
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I finished my treatment 2 years ago and have been disease-free since, confirmed by tests and doctor's exams.
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I am 18 or older with throat dryness from treatment for throat cancer.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anterior tongue pressure measured from Iowa Oral Performance Instrument (IOPI)
Study product-related, biopsy procedure-related, and injection procedure-related adverse events.
Secondary outcome measures
Incidence of patient aspiration pneumonia
Incidence of patient survival
Patient-reported dysphagia symptoms based on Eating Assessment Tool EAT10 score
+2 more
Other outcome measures
Clinical assessment of vocal quality (CAPE-V)
Patient-reported Quality of Life based on FACT-HN score
Patient-reported survey of smell and taste
+3 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: 150 x 10⁶ AMDC-GIR dosageExperimental Treatment1 Intervention
31 subjects will be receiving two doses of 150 x 10⁶ AMDC-GIR spaced 4-6 weeks apart.
Group II: Experimental: Identical Placebo composed of the same cryopreservation medium used for AMDC-GIRPlacebo Group1 Intervention
31 subjects will be receiving two doses of identical placebo composed of the same cryopreservation medium used for AMDC-GIR. Doses will be spaced 4-6 weeks apart.

Find a Location

Who is running the clinical trial?

Cook MyoSiteIndustry Sponsor
12 Previous Clinical Trials
970 Total Patients Enrolled
California Institute for Regenerative Medicine (CIRM)OTHER
63 Previous Clinical Trials
3,092 Total Patients Enrolled
University of California, DavisLead Sponsor
909 Previous Clinical Trials
4,704,068 Total Patients Enrolled

Media Library

Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05421689 — Phase 1 & 2
Oropharyngeal Dysphagia Research Study Groups: Experimental: 150 x 10⁶ AMDC-GIR dosage, Experimental: Identical Placebo composed of the same cryopreservation medium used for AMDC-GIR
Oropharyngeal Dysphagia Clinical Trial 2023: Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) Highlights & Side Effects. Trial Name: NCT05421689 — Phase 1 & 2
Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05421689 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical trial actively searching for participants?

"Affirmative. According to clinicaltrials.gov, the trial which was first shared on May 26th 2022 is still recruiting participants. 62 people are needed for 2 designated medical centres."

Answered by AI

How many individuals have been recruited for the clinical trial thus far?

"Correct. Per the information published on clinicaltrials.gov, this medical experiment is actively looking for individuals to take part in it; the trial was first advertised on May 26th 2022 and most recently updated on June 13th 2022. The study needs 62 participants from 2 sites."

Answered by AI

What is the central goal of this experiment?

"According to the study sponsor, Cook MyoSite, this 24-month trial will mainly evaluate Anterior tongue pressure using Iowa Oral Performance Instrument (IOPI). Furthermore, there are secondary objectives such as assessing patients' survival rate and incidence of aspiration pneumonia alongside dysphagia symptoms evaluated through Eating Assessment Tool EAT10. This 10 question survey ranges from 0-4 scoring criteria where 0 indicates no issue and 4 marks a severe problem."

Answered by AI
~31 spots leftby Jan 2026