REVIVE Prospective Registry Cohort Study

Prospective Observational Long-Term Safety and Effectiveness Registry of Patients Who Have Received Iltamiocel as Part of REVIVE Clinical Study in Patients With Tongue Dysphagia Resulting From the Treatment of Head and Neck Cancer

The main purpose of this registry is to collect observational, long-term safety and effectiveness data in participants who have received iltamiocel as part of the blinded portion of the REVIVE clinical study.

Study Overview

• Status: Not yet recruiting
• Conditions: Oropharyngeal Dysphagia
• Intervention / Treatment: Other: Other: No Intervention (subjects were previously treated with Iltamiocel). This is a observational study and all participants will be observed with no intervention.

Detailed Description

This is an observational registry with a non-experimental cohort design that will provide long-term safety and effectiveness data from participants who participated in the REVIVE clinical study. Participants will be enrolled by either of the two participating sites. All visits will be conducted either remotely or in person. The objectives of this study are to:

• Evaluate the long-term safety of iltamiocel
• Evaluate the long-term effectiveness of iltamiocel treatment as demonstrated through anterior tongue strength and patient reported outcomes (PROs) related to tongue dysphagia (TD) symptoms, quality of life (QOL), and overall satisfaction.

The duration of participants' participation in this registry will extend to 5 years after enrollment. This is an observational registry with a non-experimental cohort design that will provide long-term safety and effectiveness data from participants who participated in the REVIVE clinical study. Participants will be enrolled by either of the two participating sites. All visits will be conducted either remotely or in person.

• Study Type: Observational
• Enrollment (Estimated): 31

Contacts and Locations

• Study Contact: Name: Randev Sandhu, BS; Phone Number: 916-734-2863; Email: rssandhu@health.ucdavis.edu
• Study Contact Backup: Name: Johnathon Anderson, PhD; Phone Number: 916-734-2801; Email: joanderson@health.ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • UC Davis Medical Center
      • Principal Investigator: Peter Belafsky, MD
      • Sub-Investigator: Maggie Kuhn, MD
      • Contact: Peter Belafsky, MD; Phone Number: 916-734-2801; Email: pcbelafsky@health.ucdavis.edu
      • Contact: Maggie Kuhn, MD; Phone Number: 916734-2801; Email: makuhn@health.ucdavis.edu
    • San Francisco, California, United States, 94115
      • UC SanFrancisco Medical Center
      • Contact: Clark Rosen, MD; Phone Number: 415-885-7700; Email: clark.rosen@ucsf.edu
      • Contact: Yue Ma, MD; Phone Number: 415-885-7700; Email: yue.ma@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants who have received iltamiocel as part of the blinded portion of the REVIVE clinical study will be considered for enrollment. Eligibility according to inclusion and exclusion criteria is based on the participant's status at time of enrollment (Informed Consent Form (ICF) completion). All eligible participants consenting to study participation are expected to complete follow-up visits on a yearly basis.

Description

Inclusion Criteria:

• Participants who have received iltamiocel as part of participation in the REVIVE clinical study for males and females with tongue dysphagia (TD) are eligible, provided the following criteria are fulfilled:

  • Has completed the Month 24 visit in the REVIVE study.
  • Has received iltamiocel as part of the blinded portion of the REVIVE study.
  • Must be willing and able to comply with the study procedures, is able to understand all study requirements and must agree to read and sign the informed consent form prior to any study-related procedures.

Exclusion Criteria:

• The following criteria will exclude participants from participation:

  • Has received placebo as part of the blinded portion of the REVIVE study.
  • Unable or unwilling to provide informed consent.
  • Not available for, or willing to comply with the follow-up evaluations as required by the protocol.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Tongue Dysphagia Oropharyngeal Cancer; Patients with Oropharyngeal cancer who have received Iltamiocel as part of REVIVE Clinical Study

Other: Other: No Intervention (subjects were previously treated with Iltamiocel). This is a observational study and all participants will be observed with no intervention.; Participants are followed observationally to collect long-term safety and effectiveness data after prior receipt of iltamiocel in the separate Revive clinical trial; no intervention is administered as part of this registry. Long-term safety outcomes and efficacy will be separated in analysis & reporting

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Iltamiocel-Related Adverse Events and Serious Adverse Events	Iltamiocel-related adverse events (AEs) and iltamiocel-related serious adverse events (SAEs) assessed by the investigator. Long-term safety outcomes and efficacy outcomes will be separated in analysis and reporting.	From baseline through 5 years of follow-up, assessed annually
Change From Baseline in Anterior Tongue Pressure as Measured by Iowa Oral Performance Instrument (IOPI)	Anterior tongue pressure measured using the Iowa Oral Performance Instrument (IOPI). Range 0-100 kPa, where a lower number indicates less strength.	Baseline and annually up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Dysphagia Symptoms as Measured by Eating Assessment Tool (EAT-10)	Patient-reported dysphagia symptoms assessed using the Eating Assessment Tool (EAT-10) total score. Eating Assessment Tool (EAT-10), range 0-40, where higher scores indicate worse dysphagia symptoms. Survey consisting of 10 questions (see table below), each score on a scale of 0-4, with 0= no problem, 4= severe problem. 922 Belafsky et al. Eating Assessment Tool TABLE 3. EATING ASSESSMENT TOOL (EAT-10) Circle the appropriate response. To what extent are the following scenarios problematic for you?; My swallowing problem has caused me to lose weight.; My swallowing problem interferes with my ability to go out for meals.; Swallowing liquids takes extra effort.; Swallowing solids takes extra effort.; Swallowing pills takes extra effort.; Swallowing is painful.; The pleasure of eating is affected by my swallowing.; When I swallow food sticks in my throat.; I cough when I eat.; Swallowing is stressful	Baseline and annually up to 5 years
Change From Baseline in Smell and Taste Function as Measured by ChemoSensory Smell and Taste Questionnaire (CSQ)	Patient-reported smell and taste function assessed using the ChemoSensory Smell and Taste Questionnaire (CSQ). Consists of 8 items divided into two subscales: 4 items for smell and 4 items for taste and each with a range of 1 to 5, where 1 is never, 2 is Rarely, 3 is Sometimes, 4 is Frequently and 5 is Always. Each scale ranges from 4 to 20, where higher scores indicate better chemosensory function.	Baseline and annually up to 5 years
Change From Baseline in Functional Oral Intake as Measured by Functional Oral Intake Scale (FOIS)	Functional oral intake assessed using the Functional Oral Intake Scale (FOIS). It is a 7-level ordinal scale used to document the functional level of oral food and liquid intake in patients with dysphagia. It ranges from Level 1 (no oral intake/tube-dependent) to Level 7 (full oral intake without restrictions), where the higher the score the less oral intake restrictions.	Baseline and annually up to 5 years
Change From Baseline in Dysphagia-Related Quality of Life as Measured by MD Anderson Dysphagia Inventory (MDADI)	Dysphagia-related quality of life assessed using the MD Anderson Dysphagia Inventory (MDADI). It is a 20-item questionnaire that measures swallowing-related quality of life, scoring from 20 to 100. Higher scores indicate better functioning, with 20 representing the lowest and 100 the highest.	Baseline and annually up to 5 years

Collaborators and Investigators

• Sponsor: Peter Belafsky, MD
• Collaborators: Cook MyoSite
• Investigators: Principal Investigator: Peter Belafsky, MD, University of California, Davis

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2032

Study Registration Dates

• First Submitted: January 24, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 9, 2026
• Last Update Submitted That Met QC Criteria: April 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Dysphagia; Autologous; Tongue
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Otorhinolaryngologic Diseases; Pharyngeal Diseases; Deglutition Disorders
• Other Study ID Numbers: 2405778

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No