[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05598775":3,"trial-entities:NCT05598775":64,"trial-summary:NCT05598775":67},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":23,"interventions":26,"primary_outcomes":30,"secondary_outcomes":35,"sex":36,"minimum_age":37,"maximum_age":38,"healthy_volunteers":21,"eligibility_criteria":39,"std_ages":44,"locations":47,"central_contacts":57,"overall_officials":58,"references":62,"see_also_links":63},"NCT05598775","RN01-CP-0004","Long-Term Safety Study of CTX0E03 in Subjects Who Completed PISCES III Study","ENROLLING_BY_INVITATION","2026-12-31","2022-10","2023-03-31","2022-11-01","ReNeuron Limited","INDUSTRY",false,"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","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\u002FProject Physician is related to CTX0E03 DP.",[18],"Ischemic Stroke",[],"OBSERVATIONAL",null,[],{"count":24,"type":25},9,"ESTIMATED",[27],{"type":28,"name":29,"description":29},"OTHER","Non Interventional long term safety follow up",[31],{"measure":32,"description":33,"timeFrame":34},"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",[],"ALL","35 Years","75 Years",{"inclusion":40,"exclusion":41,"raw_text":43},[],[42],"None","Inclusion Criteria:\n\nSubjects who have received CTX0E03 DP as part of the active arm in the PISCES III study Have provided appropriate written informed consent\n\nExclusion Criteria:\n\n* None",[45,46],"ADULT","OLDER_ADULT",[48],{"facility":49,"city":50,"state":51,"zip":52,"country":53,"geoPoint":54},"Amy Miller, RPh, PharmD","Morgantown","West Virginia","26505","United States",{"lat":55,"lon":56},39.62953,-79.9559,[],[59],{"name":49,"affiliation":60,"role":61},"UBC","PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":65,"biomarkers":66},[18],[],{"nct_id":4,"found":14,"summary":21,"prompt_version":21}]