[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562837":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":11,"centralContacts":20,"locations":26,"responsibleParty":53,"collaborators":11,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":11,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":74,"overallStatus":29,"whyStopped":11,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":85},{"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 of brain.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":11,"email":25},"Meng Cai","CONTACT","86-027-59338180","caimeng@iregene.com",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"Tongji Hospital Affiliated to Tongji Medical College Hust","RECRUITING","Wuhan","Hubei","430030","China","CN",{"type":36,"coordinates":37},"Point",[38,39],114.26667,30.58333,{"lat":39,"lon":38},[42,46,49,50,51],{"name":43,"role":23,"phone":44,"phoneExt":11,"email":45},"Wei Wang","027-83663337","wwang@vip.126.com",{"name":47,"role":23,"phone":44,"phoneExt":11,"email":48},"Xiang Luo","flydottjh@163.com",{"name":43,"role":23,"phone":11,"phoneExt":11,"email":11},{"name":47,"role":23,"phone":11,"phoneExt":11,"email":11},{"name":52,"role":23,"phone":11,"phoneExt":11,"email":11},"Huaqiu Zhang",{"type":54,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100562837","phase-1-the-safety-tolerability-and-preliminary-efficacy-of-nouvneu001-for-early-onset-parkinsons-disease-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":66,"type":67},6,"ESTIMATED","INTERVENTIONAL",[70],"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.",[73],"Early-onset Parkinson's Disease",[73,75],"Dopaminergic Progenitor Cells","2024-11-04",{"date":78,"type":79},"2024-11-07","ACTUAL",{"date":81,"type":79},"2024-08-23",{"date":83,"type":67},"2027-03",{"name":5,"class":6},1]