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NCT05598775 Clinical Trial

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

Ischemic Stroke Clinical Trial

— LTFU  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05598775
Other study ID # RN01-CP-0004
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date November 1, 2022
Est. completion date December 31, 2026

Study information
Verified date October 2022
Source ReNeuron Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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

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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 9
Est. completion date December 31, 2026
Est. primary completion date November 1, 2026
Accepts healthy volunteers
Gender All
Age group 35 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States Amy Miller, RPh, PharmD Morgantown West Virginia

Sponsors (1)
Lead Sponsor Collaborator
ReNeuron Limited

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 4 Years
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