[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100528969":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":60,"collaborators":11,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":11,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":71,"enrollmentInfo":72,"targetDuration":11,"studyType":75,"phases":76,"briefSummary":79,"conditions":80,"keywords":82,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"iRegene Therapeutics Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"NouvNeu001","EXPERIMENTAL",null,[13],"Biological: Human Dopaminergic Progenitor Cells",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":11},"BIOLOGICAL","Human Dopaminergic Progenitor Cells","Single injection of Human Dopaminergic Progenitor Cells into the putamen\u002Fstriatum region of brain.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Meng Cai, Ph.D","CONTACT","0086-027-59337986","caimeng@iregene.com",[27,45],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Beijing Hospital","RECRUITING","Beijing","Beijing Municipality","100730","China","CN",{"type":36,"coordinates":37},"Point",[38,39],116.39723,39.9075,{"lat":39,"lon":38},[42],{"name":43,"role":23,"phone":11,"phoneExt":11,"email":44},"Haibo Chen","chenhbneuro@263.net",{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":33,"countryCode":34,"cosmosGeoPoint":51,"geoPoint":55,"contacts":56},"Zhongnan Hospital of Wuhan University","NOT_YET_RECRUITING","Wuhan","Hubei","430071",{"type":36,"coordinates":52},[53,54],114.26667,30.58333,{"lat":54,"lon":53},[57],{"name":58,"role":23,"phone":11,"phoneExt":11,"email":59},"Nanxiang Xiong","mozhuoxiong@163.com",{"type":61,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100528969","phase-1-the-safety-tolerability-and-efficacy-of-nouvneu001-for-parkinsons-disease-100528969",false,"NCT06167681","The Safety, Tolerability and Efficacy of NouvNeu001 for Parkinson's Disease","A Phase I\u002FII Study to Assess the Safety, Tolerability and Efficacy of NouvNeu001 Injection for Mid- to Late-stage Parkinson's Disease","Inclusion Criteria:\n\n* Age 50-75 years old, male or female\n* Able to understand the rationale of the clinical trial and sign informed consent form (ICF)\n* Diagnosis of Parkinson's Disease in accordance with the MDS clinical diagnostic criteria for Parkinson's disease (2015)\n* Diagnosis of Parkinson's Disease made between 4 to 20 years ago\n* Medically suitable for neurosurgery under anesthesia and able to participate in Magnetic Resonance Imaging (MRI) and Positron Emission Tomography (PET) scan.\n* Hoehn-Yahr staging for \"off\" episodes is 2.5 to 4\n* The MDS-UPDRS Part III (MDS-UPDRS-III) score in the \"off\" state \\> 35, 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, deep brain stimulation (DBS) surgery, striatal or extrapyramidal surgery, brain stereotaxy or other brain surgery; as well as other surgical procedures that are judged by the investigator to affect patient's participation in this study\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 had previous cellular therapy\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 during screening;\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 surgical contraindications, or with other surgical procedures within 6 months before screening which, in the opinion of the investigator, have an impact on this trial; Patients with other neurosurgical contraindications\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","50 Years","75 Years",{"count":73,"type":74},40,"ESTIMATED","INTERVENTIONAL",[77,78],"PHASE1","PHASE2","This clinical trial is designed to evaluate the safety, tolerability and preliminary efficacy of a single injection of NouvNeu001 (Human Dopaminergic Progenitor Cells Injection) in patients with Parkinson's disease.",[81],"Parkinson Disease",[81,83],"Dopaminergic Progenitor Cells","2024-10-30",{"date":86,"type":87},"2024-11-01","ACTUAL",{"date":89,"type":87},"2024-01-17",{"date":91,"type":74},"2029-07",{"name":5,"class":6},2]