[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05536388":3,"trial-entities:NCT05536388":85,"trial-summary:NCT05536388":88},{"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":22,"study_type":23,"primary_purpose":24,"phases":25,"enrollment_info":26,"interventions":29,"primary_outcomes":38,"secondary_outcomes":43,"sex":44,"minimum_age":45,"maximum_age":24,"healthy_volunteers":46,"eligibility_criteria":47,"std_ages":57,"locations":60,"central_contacts":79,"overall_officials":81,"references":83,"see_also_links":84},"NCT05536388","10-008","Drug Discovery for Parkinson's With Mutations in the GBA Gene","UNKNOWN","2025-07-15","2024-07","2025-03-03","2022-07-15","New York Stem Cell Foundation Research Institute","OTHER",false,"The New York Stem Cell Foundation (NYSCF) Research Institute is performing this research to accelerate Parkinson's disease research and drug development by using cells from the body (such as skin or blood cells) to make stem cells and other types of cells, conduct research on the samples, perform genetic testing, and\u002For store the samples for future use.\n\nThrough this research, researchers hope to identify future treatments or even cures for Parkinson's disease.","Researchers at the New York Stem Cell Foundation (NYSCF) Research Institute study diverse diseases, conditions, and traits by creating stem cells from biological samples. These \"pluripotent\" stem cells can become any cell in the human body, including cells that may be difficult, invasive, or impossible to obtain directly.\n\nAdditionally, researchers perform genetic testing to learn more about DNA, a material in most cells that contains instructions for the body's development and functions (such as traits like eye color and risk of certain diseases). A piece of DNA that determines the specific role of a cell is called a \"gene.\" If the instructions in a gene are abnormal, this can lead to disease.\n\nParticipation in the study involves: (1) completion of health questionnaires, (2) providing a skin and\u002For blood sample from which stem cells may be created, (3) collection of a saliva sample for genetic analysis, and (4) possible future follow-up to provide additional information or learn about other research studies.\n\nThis study is not a clinical trial.",[18,19,20,21],"Parkinson Disease","Gaucher Disease","Healthy","GBA Gene Mutation",[18,21],"OBSERVATIONAL",null,[],{"count":27,"type":28},60,"ESTIMATED",[30],{"type":13,"name":31,"description":32,"armGroupLabels":33,"otherNames":36},"Biological Sample Collection","Skin biopsy (2-3mm) and\u002For blood (up to 50 mL); saliva; excess\u002Fleftover biospecimens that were (or will be) collected for other purposes (e.g., medical procedure)",[19,34,35],"Healthy Control","Parkinson's Disease",[37],"Biological sample collection for biobanking and research",[39],{"measure":40,"description":41,"timeFrame":42},"Establishment of a diverse bank of biological samples, stem cell lines, derivatives, and associated information.","Establish a robust disease signature using a cohort of PD and carefully matched control samples to screen a library of approximately 3,000 compounds to determine whether any compounds improve or reverse disease phenotypes.","Baseline",[],"ALL","18 Years",true,{"inclusion":48,"exclusion":52,"raw_text":56},[49,50,51],"Age 18 years or older.","Diagnosis of Parkinson's disease, Gaucher disease, or healthy control.","Must provide written informed consent unless physical limitations preclude signing.",[53,54,55],"For skin samples collected specifically for this study: history of keloid formation, coagulation disorder, allergy to the anesthetic, or anticoagulation use that precludes sample collection.","For blood samples collected specifically for this study: coagulation disorder or other medical condition(s) that increases the risks associated with blood collection.","For all prospective sample collections: Subjects who refuse to adhere to NYSCF's and\u002For a collection site's safety protocols will be excluded. Subjects with an AIDS diagnosis and CD4 count of less than 200 cells per microliter (mcL) of blood will be excluded due to increased risk of infection.","Inclusion Criteria:\n\n* Age 18 years or older.\n* Diagnosis of Parkinson's disease, Gaucher disease, or healthy control.\n* Must provide written informed consent unless physical limitations preclude signing.\n\nExclusion Criteria:\n\n* For skin samples collected specifically for this study: history of keloid formation, coagulation disorder, allergy to the anesthetic, or anticoagulation use that precludes sample collection.\n* For blood samples collected specifically for this study: coagulation disorder or other medical condition(s) that increases the risks associated with blood collection.\n* For all prospective sample collections: Subjects who refuse to adhere to NYSCF's and\u002For a collection site's safety protocols will be excluded. Subjects with an AIDS diagnosis and CD4 count of less than 200 cells per microliter (mcL) of blood will be excluded due to increased risk of infection.",[58,59],"ADULT","OLDER_ADULT",[61],{"facility":62,"status":63,"city":64,"state":64,"zip":65,"country":66,"contacts":67,"geoPoint":76},"The New York Stem Cell Foundation Research Institute","RECRUITING","New York","10019","United States",[68,73],{"name":69,"role":70,"phone":71,"email":72},"Clinical Research Office","CONTACT","212-927-1801","clinicalresearch@nyscf.org",{"name":74,"role":75},"Laura Andres-Martin","PRINCIPAL_INVESTIGATOR",{"lat":77,"lon":78},40.71427,-74.00597,[80],{"name":69,"role":70,"phone":71,"email":72},[82],{"name":74,"affiliation":12,"role":75},[],[],{"nct_id":4,"conditions":86,"biomarkers":87},[19,18],[],{"nct_id":4,"found":46,"summary":89,"prompt_version":99},{"design":90,"status":91,"heading":92,"summary":93,"follow_up":94,"word_count":95,"commitments":96,"compensation":97,"drugs_mentioned":98},"This is an observational study with a planned enrollment of 60 participants. It is not a clinical trial, meaning no experimental treatments are being tested.","completed","Observational Study for Parkinson's Disease and GBA Gene Mutations","This study by the New York Stem Cell Foundation (NYSCF) Research Institute aims to accelerate Parkinson's disease research and drug development. Researchers are collecting biological samples (like skin, blood, or saliva) from people with Parkinson's disease, Gaucher disease, or healthy individuals. These samples will be used to create stem cells and other cell types, perform genetic testing, and store for future research. The goal is to build a diverse bank of these samples and information to help identify future treatments or cures for Parkinson's disease. You can join if you are 18 or older and have Parkinson's disease, Gaucher disease, or are a healthy control. The study's main goal is to establish this sample bank.","Not specified.",115,"Participation involves completing health questionnaires, providing a skin and\u002For blood sample, and a saliva sample. There may also be future follow-up for additional information or other research studies.","Not stated in the trial record.",[],"v2"]