Not Yet RecruitingNot Applicable

REVIVE Prospective Registry Cohort Study

United States31 participantsStarted 2026-08-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of Participants With Iltamiocel-Related Adverse Events and Serious Adverse Events

Timeframe: 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)

Timeframe: Baseline and annually up to 5 years

Trial details

NCT IDNCT07429890

SponsorUniversity of California, Davis

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2031-06-30

Contact for this trial

Randev Sandhu, BS

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

View on ClinicalTrials.gov More Oropharyngeal Dysphagia trials