Oropharyngeal DysphagiaNCT07429890
REVIVE Prospective Registry Cohort Study
An observational study of Oropharyngeal Dysphagia, run by University of California, Davis at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oropharyngeal Dysphagia
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Aug 2026to 30 Jun 2032
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
UC Davis Medical Center
Sacramento, California, 95817
Peter Belafsky, MD, 916-734-2801, pcbelafsky@health.ucdavis.edu
Maggie Kuhn, MD, 916734-2801, makuhn@health.ucdavis.edu
UC SanFrancisco Medical Center
San Francisco, California, 94115
Clark Rosen, MD, 415-885-7700, clark.rosen@ucsf.edu
Yue Ma, MD, 415-885-7700, yue.ma@ucsf.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Oropharyngeal Dysphagia
- Being tested
- Other: No Intervention (subjects were previously treated with Iltamiocel). This is a observational study and all participants will be observed with no intervention.
- Keywords
- Tongue, Dysphagia, Autologous
- Medical subject headings
- Deglutition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Tongue Dysphagia Oropharyngeal Cancer | Patients with Oropharyngeal cancer who have received Iltamiocel as part of REVIVE Clinical Study Receives: Other: Other: No Intervention (subjects were previously treated with Iltamiocel). This is a observational study and all participants will be observed with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and annually up to 5 years
Secondary outcomes (4)
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and annually up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study start30 Aug 2026 (estimated)
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oropharyngeal DysphagiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Cook MyoSite
- Responsible party
- Sponsor
- Investigators
- Peter Belafsky, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07429890
- Sponsor's protocol ID
- 2405778
- Status last verified
- Jun 2026
- First submitted
- 24 Jan 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07429890
- Acronym / sponsor ID
- 2405778
- Conditions
- Oropharyngeal Dysphagia
- Keywords
- Tongue, Dysphagia, Autologous
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Cook MyoSite
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2032 (estimated)
- First posted
- 24 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tongue Dysphagia Oropharyngeal Cancer | – | Other: Other: No Intervention (subjects were previously treated with Iltamiocel). This is a observational study and all participants will be observed with no intervention.Patients with Oropharyngeal cancer who have received Iltamiocel as part of REVIVE Clinical Study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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:
Key exclusion criteria (4 listed)
- The following criteria will exclude participants from participation:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Tongue Dysphagia Oropharyngeal Cancer |
Primary outcome
Number of Participants With Iltamiocel-Related Adverse Events and Serious Adverse Events
Time frame: From baseline through 5 years of follow-up, assessed annually
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.
Change From Baseline in Anterior Tongue Pressure as Measured by Iowa Oral Performance Instrument (IOPI)
Time frame: Baseline and annually up to 5 years
Anterior tongue pressure measured using the Iowa Oral Performance Instrument (IOPI). Range 0-100 kPa, where a lower number indicates less strength.
4 secondary outcomes
Change From Baseline in Dysphagia Symptoms as Measured by Eating Assessment Tool (EAT-10)
Time frame: Baseline and annually up to 5 years
Change From Baseline in Smell and Taste Function as Measured by ChemoSensory Smell and Taste Questionnaire (CSQ)
Time frame: Baseline and annually up to 5 years
Change From Baseline in Functional Oral Intake as Measured by Functional Oral Intake Scale (FOIS)
Time frame: Baseline and annually up to 5 years
Change From Baseline in Dysphagia-Related Quality of Life as Measured by MD Anderson Dysphagia Inventory (MDADI)
Time frame: Baseline and annually up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Peter Belafsky, MD principal investigator
University of California, Davis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oropharyngeal Dysphagia, run by University of California, Davis at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Randev Sandhu, BS (916-734-2863, rssandhu@health.ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Iltamiocel-Related Adverse Events and Serious Adverse Events (time frame: From baseline through 5 years of follow-up, assessed annually). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.