A Multi-Center, Double-Blind, Randomized Placebo-Controlled Investigation of Autologous Muscle Derived Cells (AMDC) for the Treatment of Tongue Dysphagia Resulting from the Treatment of Head and Neck Cancer (REVIVE)

The purpose of this double-blind, randomized, placebo-controlled, multicenter clinical trial is to evaluate the safety and efficacy of Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) for the treatment of tongue dysphagia (TD) in male and female patients who have undergone surgery and/or chemo- and/or radiotherapy for squamous cell cancer of the oropharynx.

Patients will receive two treatments of intramuscular injection of 1 AMDC-GIR dose of 150 x 10⁶ cells or identical placebo. The injections will be spaced 4-6 weeks apart. 

Patients will be assessed for improvement in TD and incidence of Adverse Events (AEs) for up to 2 years post-injection.

Sponsor

Peter Belafsy, MD, MPH, PhD

Status of enrollment

Accepting new patients

Ages Eligible for Study

For people ages 18 years and up

Disease indication

Tongue Dysphagia (TD)

Principal Investigator

Clark Rosen, MD

Contact

Claire Perrin: [email protected]

James Lappin Jr: [email protected] 

 

Additional study eligibility details can be found at UCSF Clinical Trials.