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Enrolling by invitation NCT05598775

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

— Observational Ischemic Stroke

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non Interventional long term safety follow up.
Who it may be relevant to
Registry conditions: Ischemic Stroke. Basic parameters: 35 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

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.

Interventions

  • Other Non Interventional long term safety follow up
    Non Interventional long term safety follow up

Primary outcome measures

  • Long-term safety study is to follow up subjects treated with CTX0E03 DP [Time frame: 4 Years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Amy Miller, RPh, PharmD — Morgantown

Identifiers

NCT: NCT05598775 · RN01-CP-0004

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗