[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100261519":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":23,"locations":32,"responsibleParty":43,"collaborators":45,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":23,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":23,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":71,"whyStopped":23,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Living Cell Technologies","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NTCELL","EXPERIMENTAL","NTCELL Implantation",[13],"Biological: NTCELL Implantation",{"label":15,"type":16,"description":15,"interventionNames":17},"Sham Surgery","SHAM_COMPARATOR",[18],"Other: Sham Surgery",[20,24],{"type":21,"name":11,"description":11,"armGroupLabels":22,"otherNames":23},"BIOLOGICAL",[9],null,{"type":25,"name":15,"description":15,"armGroupLabels":26,"otherNames":23},"OTHER",[15],[28],{"name":29,"affiliation":30,"role":31},"Barry Snow","Auckland City Hospital","PRINCIPAL_INVESTIGATOR",[33],{"facility":30,"status":23,"city":34,"state":23,"zip":23,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":23},"Auckland","New Zealand","NZ",{"type":38,"coordinates":39},"Point",[40,41],174.76349,-36.84853,{"lat":41,"lon":40},{"type":44,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR",[46],{"name":47,"class":48},"Statistecol Consultants Limited","UNKNOWN","100261519","phase-2-investigation-of-the-safety-and-efficacy-of-ntcell-immunoprotected-alginate-encapsulated-porcine-choroid-plexus-cells-for-xenotransplantation-in-patients-with-parkinsons-disease-100261519",false,"NCT02683629","Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's Disease","A Phase IIb, Randomised, Double-blind, Placebo-controlled, Dose-range Investigation of the Safety and Efficacy of NTCELL® [Immunoprotected (Alginate-Encapsulated) Porcine Choroid Plexus Cells for Xenotransplantation] in Patients With Parkinson's Disease","Inclusion Criteria:\n\n1. Adults (males or females) in the age range 40 to 65 years\n2. Diagnosis of Parkinson's disease (minimum duration of 5 years) in accordance with the London Brain Bank criteria\n3. Patients diagnosed with idiopathic Parkinson's disease\n4. Optimum medication for Parkinson's disease\n5. Expected to meet the criteria for DBS in the future, in the opinion of the Investigator\n6. If female, no childbearing capability (those who are more than 2 years post-menopausal or have undergone voluntary sterilisation can be considered for enrolment)\n7. Provision of written informed consent. Patients will be required to agree to comply with all tests and visits specified in the protocol, and they (and their partners\u002Fclose contacts) will also be required to consent to long-term microbiological monitoring, which is an integral part of the study\n\nExclusion Criteria:\n\n1. Any history of central nervous system infection\n2. Significant dementia as determined by neuropsychiatric assessment\n3. Focal neurological defects\n4. Evidence of significant ongoing medical or psychiatric disorders\n5. Secondary parkinsonism\n6. Severe autonomic symptoms\n7. Atypical Parkinson's disease\n8. History of substance abuse\n9. Body mass index (BMI) ≥ 30 kg\u002Fm2 or ≤ 20 kg\u002Fm2\n10. Serious comorbid conditions that, in the opinion of the Investigator, are likely to affect participation in the study, including:\n\n    1. Previous coronary heart disease manifesting as non-ST elevation myocardial infarction (NSTEMI), Q-wave infarction or unstable angina; coronary artery bypass graft (CABG); or percutaneous angioplasty\n    2. Previous cerebrovascular disease manifesting as transient ischaemic attacks (TIAs) or stroke\n    3. Peripheral vascular disease with foot ulcer and\u002For previous amputation\n    4. History of New York Heart Association (NYHA) class II, III or IV congestive heart failure (CHF) and\u002For chronic atrial fibrillation\n    5. Chronic obstructive pulmonary disease (COPD) or asthma with previous hospitalisation for decompensation; a requirement for mechanical ventilation at any stage; or long-term treatment with oral corticosteroids\n    6. Liver disease with abnormal liver function tests defined as serum bilirubin ≥ 20 µmol\u002FL, and\u002For ALT ≥ 100 U\u002FL, and\u002For GGT ≥ 100 U\u002FL, and\u002For albumin \\\u003C 35 g\u002FL\n    7. Haematological disorders, including haemoglobin ≤ 110 g\u002FL or platelet count \\\u003C 80 x 109\u002FL\n    8. Kidney disease, defined as serum creatinine \\> 130 μmol\u002FL in men and \\> 110 μmol\u002FL in women and\u002For haematuria and\u002For active urinary sediment or casts\n    9. Peptic ulcer disease and\u002For history of previous gastrointestinal bleeding\n    10. Malignancy other than basal cell carcinoma\n    11. History of epilepsy\n    12. Untreated hypothyroidism\n    13. Known adrenal insufficiency\n11. Previous brain surgery for Parkinson's disease\n12. Poor candidate for any surgery\n13. HIV antibody and\u002For risk factors for HIV infection\n14. Positive hepatitis C antibody, positive hepatitis B surface antigen, and hepatitis B core antibody\n15. Current administration of immunosuppressive medications (e.g. cyclosporin, tacrolimus, sirolimus, mycophenolate mofetil, muromonab-CD3, daclizumab, basiliximab, antithymocyte globulin, interferons) for other disease conditions\n16. Any other condition that, in the opinion of the Investigator, may interfere with adherence to the study protocol","ALL","40 Years","65 Years",{"count":60,"type":61},18,"ACTUAL","INTERVENTIONAL",[64],"PHASE2","To assess the safety of xenotransplantation of NTCELL \\[immunoprotected (alginate-encapsulated) choroid plexus cells\\] in patients with Parkinson's disease, assessed over the duration of the study, by monitoring the occurrence of adverse events and serious adverse events, including clinical and laboratory evidence of xenogeneic infection in transplant recipients and their partners\u002Fclose contacts. Subsequent safety follow-up will include lifelong monitoring for clinical and laboratory evidence of xenogeneic infection.\n\nTo assess the efficacy of xenotransplantation of NTCELL \\[immunoprotected (alginate-encapsulated) choroid plexus cells\\] in patients with Parkinson's disease. This will be quantified by testing the secondary endpoints of the trial as described below (see Endpoints\u002FOutcome Measures).",[67],"Parkinson's Disease",[67,69,70],"Xenotransplantation","choroid plexus","COMPLETED","2019-05-12",{"date":74,"type":61},"2019-05-14",{"date":76,"type":61},"2016-02",{"date":78,"type":61},"2019-05-02",{"name":5,"class":6},1]