[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562837":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":29,"studyPopulation":29,"armGroups":33,"interventions":39,"overallOfficials":29,"centralContacts":45,"locations":51,"responsibleParty":78,"collaborators":29,"id":80,"slug":29,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":29,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":29,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":54,"whyStopped":29,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"iRegene Therapeutics Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":18},[9],{"measure":10,"description":11,"timeFrame":12},"Safety and Tolerability","Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).","Enrollment to 96 weeks post-transplant.",[14],{"measure":15,"description":16,"timeFrame":17},"The Motor Function and Non-motor Function","Changes in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I-IV Score from baseline. A higher score indicates more severe symptoms or worse health.","Baseline to 48 weeks and 96 weeks post-transplant",[19,23],{"measure":20,"description":21,"timeFrame":22},"Positron Emission Tomography Imaging","Change in uptake value from baseline using positron emission tomography (PET).","Baseline to 48 weeks post-transplant.",{"measure":24,"description":25,"timeFrame":22},"Dopamine Metabolism","Change in the levels of dopamine and its metabolites from baseline.",{"allocation":27,"interventionModel":28,"interventionModelDescription":29,"primaryPurpose":30,"observationalModel":29,"timePerspective":29,"maskingInfo":31},"NA","SEQUENTIAL",null,"TREATMENT",{"masking":32,"maskingDescription":29,"whoMasked":29},"NONE",[34],{"label":35,"type":36,"description":29,"interventionNames":37},"NouvNeu001","EXPERIMENTAL",[38],"Biological: Human Dopaminergic Progenitor Cells",[40],{"type":41,"name":42,"description":43,"armGroupLabels":44,"otherNames":29},"BIOLOGICAL","Human Dopaminergic Progenitor Cells","Single injection of Human Dopaminergic Progenitor Cells into the putamen of brain.",[35],[46],{"name":47,"role":48,"phone":49,"phoneExt":29,"email":50},"Meng Cai","CONTACT","86-027-59338180","caimeng@iregene.com",[52],{"facility":53,"status":54,"city":55,"state":56,"zip":57,"country":58,"countryCode":59,"cosmosGeoPoint":60,"geoPoint":65,"contacts":66},"Tongji Hospital Affiliated to Tongji Medical College Hust","RECRUITING","Wuhan","Hubei","430030","China","CN",{"type":61,"coordinates":62},"Point",[63,64],114.26667,30.58333,{"lat":64,"lon":63},[67,71,74,75,76],{"name":68,"role":48,"phone":69,"phoneExt":29,"email":70},"Wei Wang","027-83663337","wwang@vip.126.com",{"name":72,"role":48,"phone":69,"phoneExt":29,"email":73},"Xiang Luo","flydottjh@163.com",{"name":68,"role":48,"phone":29,"phoneExt":29,"email":29},{"name":72,"role":48,"phone":29,"phoneExt":29,"email":29},{"name":77,"role":48,"phone":29,"phoneExt":29,"email":29},"Huaqiu Zhang",{"type":79,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR","100562837",false,"NCT06608355","The Safety, Tolerability and Preliminary Efficacy of NouvNeu001 for Early-onset Parkinson's Disease","A Phase I Study to Assess the Safety, Tolerability and Preliminary Efficacy of NouvNeu001 Injection in the Treatment of Early-onset Parkinson's Disease","Inclusion Criteria:\n\n* Age 18-70 years old, male or female\n* Able to understand the rationale of the clinical trial and sign informed consent form (ICF)\n* Diagnosis of Early-onset Parkinson's Disease in accordance with the MDS clinical diagnostic criteria for Parkinson's disease, and the age of onset was ≤50 years old\n* Medically suitable for neurosurgery under anesthesia and able to participate in Computed Tomography (CT)\u002FMagnetic Resonance Imaging (MRI) scan.\n* Hoehn-Yahr staging for \"off\" episodes is 2 to 4\n* The MDS-UPDRS-III score in the \"off\" state \\>30, and positive for the Acute Levodopa Challenge Test (ALCT)\n* Acceptable laboratory test results during screening and prior to transplantation\n\nExclusion Criteria:\n\n* Atypical Parkinsonism\n* Patients who have had previous pallidotomy, striatal or extrapyramidal surgery or other brain surgery; as well as other surgical procedures that are judged by the investigator to affect patient's participation in this study; Patients with surgical contraindications or other neurosurgical contraindications\n* Patients who have a previous head CT\u002FMRI examination showing cerebral trauma, vascular malformation, hydrocephalus, brain tumor, etc., and patients who have brain imaging abnormalities in the striatum or other brain areas leading to a significantly increased risk for surgery\n* Patients with a history of severe cardiovascular and cerebrovascular diseases\n* Patients with a history of malignant tumors\n* Patients who have received stem cell therapy for Parkinson's disease within 2 years before signing the ICF\n* Patients with active disseminated intravascular coagulation and significant hemorrhagic tendency within 3 months prior to screening, or who cannot temporarily suspend anti-platelet agents or other anti-coagulant medications for at least 5 days before surgery\n* Patients with long-term, heavy use of glucocorticoids or immunosuppressive drugs within 3 months prior to signing the ICF\n* Patients with a history of mental illness who are deemed unfit to participate in the study by the investigator; or a history of suicidal ideation or suicide attempts within the past year or currently\n* Patients who have used botulinum toxin within 6 months prior to signing the ICF\n* Patients with active epilepsy or currently on anti-epileptic drugs\n* Patients with a history of dementia or severe cognitive disorder, or the score of MDS-UPDRS 1.1 during screening is \\> 3; poor compliance, inability to accurately keep diary, and\u002For inability to sign ICF due to dementia\n* Patients with severe depression or with severe anxiety\n* Patients with the following abnormalities during screening, including: Abnormal coagulation; Abnormal immunological tests, and assessed by the investigator it is not suitable to participate in the trial; Hypertensive patients with poorly controlled blood pressure and patients with severe postural hypotension; Diabetic patients with poorly controlled blood glucose\n* Patients with other combined severe systemic diseases, such as pulmonary heart disease, moderate to severe asthma, severe chronic obstructive pulmonary disease (COPD)\n* Presence of one of the following: positive for human immunodeficiency virus (HIV) antibody, treponema pallidum antibody, hepatitis C virus (HCV) antibody and HCV RNA; Hepatitis B virus (HBV) surface antigen positive and HBV DNA copy number \\> detection of normal values; Tuberculosis is in the active stage; Other active infections that the investigator believes may affect Patients' participation in the study or affect study outcomes\n* Patients with alcohol addiction or positive for drug of abuse testing\n* Patients with a history of contraindication or allergy to the drugs used during the study or any of its components, or are allergic to the same drugs or other macrolides, or have allergies\n* Female of childbearing potential who are not surgically sterilized\u002Fpremenopausal\u002Funwilling to use medically approved effective contraception with 2 years after administration of investigational drug and lactating women; men who are not surgically sterilized\u002Funwilling to use medically approved effective contraception with 2 years after administration of investigational drug\n* Patients who have received electric shock therapy within 30 days prior to surgery\n* Patients who are participating in other clinical trials, or have been enrolled in other clinical studies and received intervention therapy within 3 months prior to the surgery\n* Patients with poor compliance based on clinical evaluation of the investigator\n* Patients who are being treated with drugs such as apomorphine, or levodopa\u002Fcarbidopa infusion therapy\n* Patients with severe dyskinesia in both on- and off-drug states","ALL","18 Years","70 Years",{"count":90,"type":91},6,"ESTIMATED","INTERVENTIONAL",[94],"PHASE1","The goal of this clinical trial is to learn about the safety of NouvNeu001 injection in Early-onset Parkinson's Disease (EOPD) patients. It will also learn about the effects of NouvNeu001 treatment. The main questions it aims to answer are:\n\nWhat medical problems do participants have when transplanting NouvNeu001 into bilateral putamen using stereotactic neurosurgery? Does injection of NouvNeu001 improve the motor function and non-motor function in participants?\n\nParticipants will:\n\nBe injectioned the NouvNeu001 into bilateral putamen using stereotactic neurosurgery.\n\nTake immunosuppressants to prevent potential immune rejection for 24 to 36 weeks.",[97],"Early-onset Parkinson's Disease",[97,99],"Dopaminergic Progenitor Cells","2024-11-04",{"date":102,"type":103},"2024-11-07","ACTUAL",{"date":105,"type":103},"2024-08-23",{"date":107,"type":91},"2027-03",{"name":5,"class":6},1]