A clinical trial of autologous muscle derived cells for treatment of tongue dysphagia

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The research company University of California, Davis is conducting the clinical trial 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 radiotherapy for squamous cell cancer of the oropharynx.

It is planned to include 62 participants.

Actual study start date is May 26, 2022. The researchers expect to complete the study by January 31, 2026.

One primary outcome measure is Anterior tongue pressure measured from Iowa Oral Performance Instrument (IOPI), Efficacy of AMDC-GIR in the improvement of objective Anterior Tongue Pressure Measurement (IOPI).

 

Further details can be found here https://ichgcp.net/clinical-trials-registry/NCT05421689 or https://clinicaltrials.gov/ct2/show/NCT05421689.

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