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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

Must not have

History of bleeding diathesis or uncorrectable coagulopathy

Any condition, including current infection or immunodeficiency, which could lead to significant postoperative complications

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a bleeding disorder that cannot be corrected.

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I have a condition that could cause serious problems after surgery.

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My diabetes is not under control.

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I have severe scarring where I've been injected before.

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I have a condition like Parkinson's, muscular dystrophy, or MS.

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My immune system is weak due to a condition, steroid use, or other treatments.

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My TD is due to nerve damage or a birth defect that hasn't been fixed.

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I cannot or do not want to continue my current therapy, like swallowing therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Anterior tongue pressure measured from Iowa Oral Performance Instrument (IOPI)

Study product-related, biopsy procedure-related, and injection procedure-related adverse events.

Secondary study objectives

Incidence of patient aspiration pneumonia

Incidence of patient survival

Patient-reported dysphagia symptoms based on Eating Assessment Tool EAT10 score

+2 more

Other study objectives

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.

0 / 11Eligibility criteria met