New registry to track Long-Term safety of experimental tongue dysphagia treatment
NCT ID NCT07429890
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study is a long-term registry for people who received the experimental drug iltamiocel in a previous study for tongue swallowing problems caused by head and neck cancer treatment. The goal is to monitor safety and see if the drug continues to help with swallowing over time. About 31 participants will be followed for several years.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 31 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UC Davis Medical Center
Sacramento, California, 95817, United States
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UC SanFrancisco Medical Center
San Francisco, California, 94115, United States
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Other studies related to the condition(s) this trial covers.
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