Long-Term Safety Study of CTX0E03 in Subjects Who Completed PISCES III Study
LTFU
1 other identifier
observational
9
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2022
CompletedFirst Posted
Study publicly available on registry
October 28, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
March 31, 2023
October 1, 2022
4 years
October 25, 2022
March 28, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Interventions
Non Interventional long term safety follow up
Eligibility Criteria
Subjects who have received CTX0E03 DP as part of the active arm in the PISCES III study
You may qualify if:
- Subjects who have received CTX0E03 DP as part of the active arm in the PISCES III study Have provided appropriate written informed consent
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ReNeuron Limitedlead
Study Sites (1)
Amy Miller, RPh, PharmD
Morgantown, West Virginia, 26505, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Miller, RPh, PharmD
UBC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2022
First Posted
October 28, 2022
Study Start
November 1, 2022
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
March 31, 2023
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share