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

ReNeuron

Status: Invitation-only

Conditions: Ischemic Stroke

Treatments: Other: Non Interventional long term safety follow up

Study type: Observational

Funder types: Industry

Identifiers

NCT05598775

RN01-CP-0004

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 estimated patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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