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

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

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

35 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Amy Miller, RPh, PharmD

Morgantown, West Virginia, 26505, United States

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non Interventional long term safety follow up

Other

Non Interventional long term safety follow up

Primary outcomes

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

Time frame: 4 Years

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

Sponsors and collaborators

Lead sponsor

ReNeuron Limited

Industry

Registry information

Acronym: LTFU

Important dates

Study start: 2022
Primary completion: 2026
Study completion: 2026
First posted: Oct 28, 2022
Registry last updated: Mar 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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