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Autologous Muscle Derived Cells for Treatment of Tongue Dysphagia

NCT05421689 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-12-12

No results posted yet for this study

Summary

The primary objective of this double-blind, randomized, placebo-controlled, multicenter clinical trial is to evaluate the safety of AMDC-GIR during the 24 months following 2 consecutive treatments 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

BIOLOGICAL

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

The study will treat 66 patients at 2 clinical sites: UC Davis Center for Voice and Swallowing and UCSF Voice and Swallowing Center. Patients will be randomized 1:1 to receive either 2 AMDC-GIR doses of 150 x 10⁶ cells or 2 doses of identical placebo composed of the same cryopreservation medium used for AMDC-GIR. Enrollment is expected to be completed within 2 years of initiating the study. Patients will be followed for 24 months post-treatment.

OTHER

Placebo

two doses of placebo will be administered and spaced 4-6 weeks apart.

Sponsors & Collaborators

  • California Institute for Regenerative Medicine (CIRM)

    collaborator OTHER

  • Cook MyoSite

    collaborator INDUSTRY

  • University of California, Davis

    lead OTHER

Principal Investigators

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

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

  • Johnathon D Anderson, PhD · University of California Davis, Department of Otolaryngology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-26
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 NCT05421689 on ClinicalTrials.gov