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NCT Number: NCT07429890

REVIVE Prospective Registry Cohort Study

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.

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Key information

Conditions

Oropharyngeal Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Davis Medical Center, Sacramento, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

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

    Time frame: Baseline and annually up to 5 years

    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

  2. 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

    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.

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

    Time frame: Baseline and annually up to 5 years

    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.

  4. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Johnathon Anderson, PhD

CONTACT

[email protected]

916-734-2801

Randev Sandhu, BS

CONTACT

[email protected]

916-734-2863

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Cook MyoSite

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Feb 24, 2026
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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