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

NCT ID: NCT05598775

Last Updated: 2023-03-31

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 9 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-01
• Study Completion Date: 2026-12-31

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.

Conditions

Ischemic Stroke

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Non Interventional long term safety follow up

Non Interventional long term safety follow up

Intervention Type: OTHER

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ReNeuron Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Miller, RPh, PharmD

Role: PRINCIPAL_INVESTIGATOR

UBC

Locations

Amy Miller, RPh, PharmD

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

RN01-CP-0004

Identifier Type: -

Identifier Source: org_study_id