REVIVE Prospective Registry Cohort Study

NCT07429890 | Not Yet Recruiting DMC FDA Drug

• 1 other identifier: 2405778
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Oropharyngeal Dysphagia

Keywords

Tongue; Dysphagia; Autologous

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Change From Baseline in Dysphagia Symptoms as Measured by Eating Assessment Tool (EAT-10)

  Baseline and annually up to 5 years

• Change From Baseline in Smell and Taste Function as Measured by ChemoSensory Smell and Taste Questionnaire (CSQ)

  Baseline and annually up to 5 years

• Change From Baseline in Functional Oral Intake as Measured by Functional Oral Intake Scale (FOIS)

  Baseline and annually up to 5 years

• Change From Baseline in Dysphagia-Related Quality of Life as Measured by MD Anderson Dysphagia Inventory (MDADI)

  Baseline and annually up to 5 years

Study Arms (1)

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.

Interventions

Other: No Intervention (subjects were previously treated with Iltamiocel). This is a observational study and all participants will be observed with no intervention. OTHER

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

Tongue Dysphagia Oropharyngeal Cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cook MyoSite: collaborator
• University of California, Davis: lead

Study Sites (2)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

UC SanFrancisco Medical Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Deglutition Disorders

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Study Officials

• Peter Belafsky, MD

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Randev Sandhu, BS

CONTACT

916-734-2863; rssandhu@health.ucdavis.edu

Johnathon Anderson, PhD

CONTACT

916-734-2801; joanderson@health.ucdavis.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2026
• First Posted: February 24, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): June 30, 2031
• Study Completion (Estimated): June 30, 2032
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)