University of California, Davis
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.
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…
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: *…
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
Arctuva estimate
Verify or correct the compensation shown for this listing.