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

• Conditions: Ischemic Stroke

• Registration Number: NCT05598775
• Lead Sponsor: ReNeuron Limited

Brief 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.

Study Timeline

• Status Verified: 2022-10
• Study First Submitted: 2022-10-25
• Study First Submitted QC: 2022-10-25
• Study First Posted: 2022-10-28
• Study Start: 2022-11-01
• Last Update Submitted: 2023-03-28
• Last Update Posted: 2023-03-31
• Primary Completion: 2026-11-01
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Subjects who have received CTX0E03 DP as part of the active arm in the PISCES III study Have provided appropriate written informed consent

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Long-term safety study is to follow up subjects treated with CTX0E03 DP	4 Years	Identify delayed oncological, neurological, and CTX0E03 DP-related adverse events and to monitor survival.

Trial Locations

Locations (1)

Amy Miller, RPh, PharmD; 🇺🇸 Morgantown, West Virginia, United States