REVIVE Prospective Registry Cohort Study
ConditionOropharyngeal Dysphagia
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, Davis
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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 design
Treatments tested in this trial
- Other: No Intervention (subjects were previously treated with Iltamiocel). This is a observational study and all participants will be observed with no intervention.
Treatment groups
31 Participants
are divided into 1 treatment groupSponsors and collaborators
University of California, Davis
Lead sponsor
Cook MyoSite
Collaborator
Source ClinicalTrials.gov