Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) for Tongue Dysphagia

NCT02838316 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 801019801019-1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oropharyngeal Dysphagia

Outcome Measures

Primary Outcomes (2)

• Study product-related Serious Adverse Events (SAEs)

  Evaluate the safety of AMDC-GIR following treatment of tongue dysphagia

  24 months

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

  Safety will be determined by the frequency and severity of adverse events related to study procedures and study product

  24 months

Secondary Outcomes (9)

• Penetration-Aspiration scale rating from swallowing fluoroscopy

  24 months

• Pharyngeal Constriction Ratio measurement from swallowing fluoroscopy

  24 months

• Upper Esophageal Sphincter opening measurement from swallowing fluoroscopy

  24 months

• Pharyngeal transit time measurement from swallowing fluoroscopy

  24 months

• Peak pharyngeal pressure measurement from high-resolution manometry

  24 months

Study Arms (2)

150 x 106 dosage

EXPERIMENTAL

10 subjects will be receiving a dosage of 150 x 106 AMDC-GIR

Drug: Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR)

300 x 106 dosage

EXPERIMENTAL

10 subjects will be receiving a dosage of 300 x 106 AMDC-GIR

Drug: Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR)

Interventions

Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) DRUG

Autologous muscle derived stem cells

150 x 106 dosage; 300 x 106 dosage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patient History-based 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.
• Moderate or severe fibrosis at likely injection site.
• Morbidly obese (BMI ≥ 35).
• Uncontrolled diabetes.
• Compromised immune system due to disease state, chronic corticosteroid use, or other immunosuppressive therapy.
• Medical condition or disorder that may limit life expectancy or that may cause clinical investigation plan (CIP) deviations (e.g., unable to perform self-evaluations or accurately report medical history, symptoms, or data).
• History of bleeding diathesis or uncorrectable coagulopathy.
• Any non-skin cancer that has necessitated treatment within the past 24 months.
• Patient's Current Status-based Criteria:

Sponsors & Collaborators

• Peter Belafsky, MD: lead
• Cook MyoSite: collaborator

Study Sites (1)

UC Davis Medical Center, Department of Otolaryngology, Head and Neck Surgery

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Peter Belafsky, MD, PhD

  University of California Davis, Department of Otolaryngology

  PRINCIPAL INVESTIGATOR

• Maggie Kuhn, MD

  University of California Davis, Department of Otolaryngology

  PRINCIPAL INVESTIGATOR

• Nogah Nativ, PhD

  University of California Davis, Department of Otolaryngology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor and Director of Voice and Swallowing Center,UC Davis Health System-Department of Otolaryngology

Model Details: Phase I open label clinical trial

Study Record Dates

• First Submitted: July 12, 2016
• First Posted: July 20, 2016
• Study Start: May 24, 2017
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 20, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)