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

NCT02838316 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-20

No results posted yet for this study

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

Interventions

DRUG

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

Autologous muscle derived stem cells

Sponsors & Collaborators

  • Cook MyoSite

    collaborator INDUSTRY

  • Peter Belafsky, MD

    lead OTHER

Principal Investigators

  • Peter Belafsky, MD, PhD · University of California Davis, Department of Otolaryngology

  • Maggie Kuhn, MD · University of California Davis, Department of Otolaryngology

  • Nogah Nativ, PhD · University of California Davis, Department of Otolaryngology

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-24
Primary Completion
2026-12-31
Completion
2026-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02838316 on ClinicalTrials.gov