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

N/AEnrolling By InvitationNCT05598775

ReNeuron Limited9 enrolled

Overview

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

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 Type

OBSERVATIONAL

Enrollment

Conditions

Ischemic Stroke

Interventions

Non Interventional long term safety follow upOTHER

Non Interventional long term safety follow up

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Amy Miller, RPh, PharmD

Morgantown, West Virginia, United States

Outcomes

Primary Outcomes

Long-term safety study is to follow up subjects treated with CTX0E03 DP

Identify delayed oncological, neurological, and CTX0E03 DP-related adverse events and to monitor survival.

Time frame: 4 Years

Data from ClinicalTrials.gov

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