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NCT05421689 · ClinicalTrials.gov registry record · Phase 1
Autologous Muscle Derived Cells for Treatment of Tongue Dysphagia
A Phase 1 study of Oropharyngeal Dysphagia, sponsored by University of California, Davis.
- Active
- Registry status
- Phase 1
- Development phase
- 66
- Enrollment target
- 2
- Study locations
NCT05421689: Active Phase 1 study of Oropharyngeal Dysphagia, sponsored by University of California, Davis.
NCT05421689 is a Phase 1 study of Oropharyngeal Dysphagia that is active but no longer recruiting, run by University of California, Davis. The registered enrollment target is 66 participants, below the 101-participant average among 7 other Oropharyngeal Dysphagia trials with a reported enrollment target (35% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05421689, a Phase 1 study of Oropharyngeal Dysphagia, is active but no longer recruiting, sponsored by University of California, Davis.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 66 participants
- Enrollment target
- 2
- Study locations
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.
Primary Outcome
Safety will be determined by the frequency and severity of adverse events related to study procedures and study product.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR)
Study Locations (2)
California
- UC Davis Medical Center, Department of Otolaryngology - Sacramento
- UC San Francisco Medical Center, Voice and Swallow Center - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2022-05-26 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 1 |
What the registry record for NCT05421689 still lists
NCT05421689 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 101-participant average among 7 other Oropharyngeal Dysphagia trials with a reported enrollment target (35% lower).
The record links to 1 condition, with Oropharyngeal Dysphagia appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05421689 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT05421689 about?
NCT05421689 is a clinical study titled "Autologous Muscle Derived Cells for Treatment of Tongue Dysphagia". 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 radioth...
What is the current status of trial NCT05421689?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2022-05-26. Estimated completion is 2026-12-31.
What conditions does trial NCT05421689 study?
This clinical trial studies the following conditions: Oropharyngeal Dysphagia.
What interventions are being tested in trial NCT05421689?
The interventions under investigation include: Placebo (OTHER), Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05421689?
This trial is sponsored by University of California, Davis, which has 657 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05421689 being conducted?
This trial has 2 study locations across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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