Experimental: 150 x 10⁶ AMDC-GIR dosage for Esophageal Dysphagia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
UC San Francisco Medical Center, Voice and Swallow Center, San Francisco, CA
Esophageal Dysphagia+1 More
Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) - Biological
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions

  • Esophageal Dysphagia
  • Oropharyngeal Dysphagia (OPD)

Treatment Effectiveness

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 24 months

24 months
Anterior tongue pressure measured from Iowa Oral Performance Instrument (IOPI)
Clinical assessment of vocal quality (CAPE-V)
Incidence of patient aspiration pneumonia
Incidence of patient survival
Patient-reported Quality of Life based on FACT-HN score
Patient-reported dysphagia symptoms based on Eating Assessment Tool EAT10 score
Patient-reported survey of smell and taste
Peak Pharyngeal pressure measurement from high-resolution manometry
Penetration Aspiration scale rating following swallowing fluoroscopy
Pharyngeal Constriction Ratio measurement for swallowing fluoroscopy
Pharyngeal transit time measurement for swallowing fluoroscopy
Study product-related, biopsy procedure-related, and injection procedure-related adverse events.
Upper Esophageal Sphincter opening measurement for swallowing fluoroscopy

Trial Safety

Trial Design

2 Treatment Groups

Experimental: 150 x 10⁶ AMDC-GIR dosage
1 of 2
Experimental: Identical Placebo composed of the same cryopreservation medium use...
1 of 2
Experimental Treatment
Non-Treatment Group

62 Total Participants · 2 Treatment Groups

Primary Treatment: Experimental: 150 x 10⁶ AMDC-GIR dosage · Has Placebo Group · Phase 1 & 2

Experimental: 150 x 10⁶ AMDC-GIR dosage
Biological
Experimental Group · 1 Intervention: Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) · Intervention Types: Biological
Experimental: Identical Placebo composed of the same cryopreservation medium used for AMDC-GIR
Other
ShamComparator Group · 1 Intervention: Placebo · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months
Closest Location: UC San Francisco Medical Center, Voice and Swallow Center · San Francisco, CA
Photo of San Francisco  1Photo of San Francisco  2Photo of San Francisco  3
N/AFirst Recorded Clinical Trial
0 TrialsResearching Esophageal Dysphagia
0 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You are 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.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.