[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05897957":3,"trial-entities:NCT05897957":104,"trial-summary:NCT05897957":107},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":29,"primary_purpose":30,"phases":31,"enrollment_info":32,"interventions":35,"primary_outcomes":36,"secondary_outcomes":41,"sex":58,"minimum_age":59,"maximum_age":60,"healthy_volunteers":15,"eligibility_criteria":61,"std_ages":67,"locations":70,"central_contacts":96,"overall_officials":97,"references":102,"see_also_links":103},"NCT05897957","BRT-DA01-501","Continued Evaluation of Patients With Parkinson's Disease Who Previously Received BRT-DA01","Continued Evaluation of Patients With Parkinson's Disease Who Previously Received BRT-DA01, a Human Embryonic Stem Cell-Derived Midbrain Dopaminergic Neuronal Cell Therapy","ENROLLING_BY_INVITATION","2027-09","2024-04","2024-04-12","2023-05-16","BlueRock Therapeutics","INDUSTRY",false,"This is a multicenter study to evaluate the safety and clinical outcomes of BRT-DA01 in subjects with PD who previously received BRT-DA01 in the Phase 1 Study MSK-DA01-101.No investigational therapy will be administered in this study.","All subjects who received BRT-DA01 transplantation in Study MSK-DA01-101 (ie, parent study) will be asked to enroll in Study BRT-DA01-501. Subjects enrolled in this study are to be monitored for safety and clinical outcomes through 5 years post-BRT-DA01 transplantation. For individual participating subjects, the Baseline visit for the BRT-DA01-501 study will be defined as the last observation recorded in the parent study.",[19],"Parkinson Disease",[19,21,22,23,24,25,26,27,28],"Parkinsonian Disorders","Basal Ganglia Diseases","Brain Diseases","Central Nervous System Diseases","Nervous System Diseases","Movement Disorders","Synucleinopathies","Neurodegenerative Diseases","OBSERVATIONAL",null,[],{"count":33,"type":34},12,"ESTIMATED",[],[37],{"measure":38,"description":39,"timeFrame":40},"Total SAEs and total number of subjects with at least 1 SAE","Total SAEs and total number of subjects with at least 1 SAE related to cellular drug product","Baseline through 5 years post-transplantation",[42,44,46,49,52,55],{"measure":43,"description":43,"timeFrame":40},"Change in striatal 18F-DOPA uptake using positron emission tomography (PET)",{"measure":45,"description":45,"timeFrame":40},"Change in Hauser PD diary measurements",{"measure":47,"description":48,"timeFrame":40},"Change in the International Parkinson and Movement Disorder Society (MDS)-Unified Parkinson's Disease Rating Scale (UPDRS)","Change in the MDS-UPDRS",{"measure":50,"description":51,"timeFrame":40},"Change in levodopa equivalent daily dose (LEDD)","Change in LEDD",{"measure":53,"description":54,"timeFrame":40},"Change in Parkinson's Disease Questionnaire-39 (PDQ-39) summary index","Change in PDQ-39",{"measure":56,"description":57,"timeFrame":40},"Change in the Unified Dyskinesia Rating Scale (UDysRS)","Change in UDysRS","ALL","50 Years","78 Years",{"inclusion":62,"exclusion":65,"raw_text":66},[63,64],"Subject received BRT-DA01 in Study MSK-DA01-101 (ie, parent study) and will have completed or discontinued the parent study","Subject must be willing and able to provide written informed consent for the BRT-DA0-501 study in accordance with applicable regulations and guidelines and to comply with all study visits and procedures",[],"Inclusion Criteria:\n\n* Subject received BRT-DA01 in Study MSK-DA01-101 (ie, parent study) and will have completed or discontinued the parent study\n* Subject must be willing and able to provide written informed consent for the BRT-DA0-501 study in accordance with applicable regulations and guidelines and to comply with all study visits and procedures\n\nExclusion Criteria:\n\n* No exclusion criteria",[68,69],"ADULT","OLDER_ADULT",[71,80,87],{"facility":72,"city":73,"state":74,"zip":75,"country":76,"geoPoint":77},"University of California, Irvine","Orange","California","92868","United States",{"lat":78,"lon":79},33.78779,-117.85311,{"facility":81,"city":82,"state":82,"zip":83,"country":76,"geoPoint":84},"Weill Cornell Medical College","New York","10065",{"lat":85,"lon":86},40.71427,-74.00597,{"facility":88,"city":89,"state":90,"zip":91,"country":92,"geoPoint":93},"Toronto Western Hospital","Toronto","Ontario","M5T 2S8","Canada",{"lat":94,"lon":95},43.70643,-79.39864,[],[98],{"name":99,"affiliation":100,"role":101},"Nauman Abid, MD","BlueRock Therapeutics LP","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":105,"biomarkers":106},[19],[],{"nct_id":4,"found":15,"summary":30,"prompt_version":30}]