Ischemic Stroke
Conditions
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.
Interventions
OTHERNon Interventional long term safety follow up
Non Interventional long term safety follow up
Sponsors
ReNeuron Limited
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
35 Years to 75 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Long-term safety study is to follow up subjects treated with CTX0E03 DP | 4 Years | Identify delayed oncological, neurological, and CTX0E03 DP-related adverse events and to monitor survival. |
Countries
United States
Outcome results
None listed