NCT05598775

Long-Term Safety Study of CTX0E03 in Subjects Who Completed PISCES III Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 9 (estimated)
• Sponsor: ReNeuron Limited · Industry
• Sex: All
• Age: 35 Years – 75 Years
• Healthy volunteers: —

Summary

The purpose of this long-term safety study is to follow up subjects treated with CTX0E03 DP to monitor for delayed oncological, neurological, and CTX0E03 DP-related adverse events and to monitor survival

Detailed description

The goal of this study is to assess the long-term safety of subjects treated with intracerebral CTX0E03 DP as measured by the onset of delayed adverse events of special interest (AESIs). AESIs are defined as adverse events leading to death, new oncological adverse events, new neurological adverse events and any other adverse event, which in the opinion of the Safety/Project Physician is related to CTX0E03 DP.

Conditions

• Ischemic Stroke

Interventions

Type	Name	Description
OTHER	Non Interventional long term safety follow up	Non Interventional long term safety follow up

Timeline

• Start date: 2022-11-01
• Primary completion: 2026-11-01
• Completion: 2026-12-31
• First posted: 2022-10-28
• Last updated: 2023-03-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study