Long-Term Safety Study of CTX0E03 in Subjects Who Completed PISCES III Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- ReNeuron Limited
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Long-term safety study is to follow up subjects treated with CTX0E03 DP
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 35 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Outcomes
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.
Secondary Outcomes
No secondary outcomes reported