REVIVE Prospective Registry Cohort Study
Part of paid clinical trials in Sacramento, California.
- Sponsor
- Peter Belafsky, MD
- Study ID
- NCT07429890
- Status
- Not Yet Recruiting
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Conditions
- Oropharyngeal Dysphagia
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Other: No Intervention (subjects were previously treated with Iltamiocel). This is a observational study and all participants will be observed with no intervention. — OTHERParticipants 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 Details
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.
Key Dates
- Start date
- Apr 30, 2026
- Status verified
- Feb 2026
- Primary completion
- Jun 30, 2031
- Completion
- Jun 30, 2032
Study Design
- Enrollment
- 31 participants (estimated)
Arms
- Arm: Tongue Dysphagia Oropharyngeal CancerPatients with Oropharyngeal cancer who have received Iltamiocel as part of REVIVE Clinical Study
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 ]
Central Contacts
- Randev Sandhu, BS916-734-2863
- Johnathon Anderson, PhD916-734-2801
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UC Davis Medical Center | Sacramento | California | 95817 | Peter Belafsky, MD (PRINCIPAL_INVESTIGATOR) Maggie Kuhn, MD (SUB_INVESTIGATOR) |
| UC SanFrancisco Medical Center | San Francisco | California | 94115 |
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