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.
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
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.
