drugset / Trial / NCT05421689
Autologous Muscle Derived Cells for Treatment of Tongue Dysphagia
Phase 1/2
Active not recruiting
66 enrolled
University of California, Davis
California Institute for Regenerative Medicine (CIRM) · collabCook MyoSite · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2022-05-26
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | AMDC-GIR | Cell therapy | 150 cells | Intramuscular |