Autologous Muscle Derived Cells for Swallowing Disorders

(REVIVE Trial)

Recruiting at1 trial location

Overseen by Maggie Kuhn, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Waitlist Available

Sponsor: University of California, Davis

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Peter Belafsky, MD

Principal Investigator

University of California Davis, Department of Otolaryngology

Maggie Kuhn, MD

Principal Investigator

University of California Davis, Department of Otolaryngology

Johnathon D Anderson, PhD

Principal Investigator

University of California Davis, Department of Otolaryngology

Eligibility Criteria

This trial is for adults who have trouble swallowing (tongue dysphagia) after treatment for oropharyngeal cancer. They must be at least 18, finished with cancer treatment for over two years, and not responding to current therapies. People can't join if they've had recent other trials, uncontrolled diabetes, immune issues, certain allergies, active cancers besides skin cancer, or are pregnant.

Inclusion Criteria

My swallowing difficulty is moderate, and I can eat some or most foods.

I finished my treatment 2 years ago and have been disease-free since, confirmed by tests and doctor's exams.

I am 18 or older with throat dryness from treatment for throat cancer.

Exclusion Criteria

My doctor says my cancer is likely to come back or not go away.

I do not have a bleeding disorder that cannot be corrected.

I have a condition that could cause serious problems after surgery.

Treatment Details

Interventions

• Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR) (Stem Cell Therapy)

Trial Overview The study tests the safety of injecting one's own muscle cells (AMDC-GIR) into the tongue versus a placebo in improving swallowing difficulties. Participants will receive two treatments and be monitored over 24 months in this double-blind study where neither they nor the researchers know who gets which treatment.

Participant Groups

Group I: Experimental: 150 x 10⁶ AMDC-GIR dosage Experimental Treatment 1 Intervention

33 subjects will be receiving two doses of 150 x 10⁶ AMDC-GIR spaced 4-6 weeks apart.

Group II: Experimental: Identical Placebo composed of the same cryopreservation medium used for AMDC-GIR Placebo Group 1 Intervention

33 subjects will be receiving two doses of identical placebo composed of the same cryopreservation medium used for AMDC-GIR. Doses will be spaced 4-6 weeks apart.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Rakesh Dixit

University of California, Davis

Chief Executive Officer since 2024

PhD in Biochemistry and Molecular Biology from the University of California, Davis

Suresh Mahabhashyam

University of California, Davis

Chief Medical Officer since 2020

MD from Bangalore Medical College

Cook MyoSite

Industry Sponsor

Trials

14

Recruited

1,100+

California Institute for Regenerative Medicine (CIRM)

Collaborator

Trials

70

Recruited

3,300+

Jonathan Thomas

California Institute for Regenerative Medicine (CIRM)

Chief Executive Officer

BA in Biology and History from Yale University, JD from Yale Law School, PhD in Commonwealth History from Oxford University

Rosa Canet-Avilés

California Institute for Regenerative Medicine (CIRM)

Chief Medical Officer since 2024

PhD in Neuroscience from Leeds University, BS in Organic Chemistry from Central University of Barcelona