drugset / Trial / NCT02838316

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

NCT02838316 ↗

Phase 1 Active not recruiting 18 enrolled Peter Belafsky, MD Cook MyoSite · collab
Non-randomizedSingle-groupOpen-labelTreatment

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.

Timeline

Start
2017-05-24
Primary completion
2026-12
Completion
2026-12

Drugs

EvaluationDrugModalityDoseRoute
Subject AMDC-GIR Cell therapy 1.5e+08 cells Intramuscular
Subject AMDC-GIR Cell therapy 3e+08 cells Intramuscular

Indications