[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"idiopathic-parkinsons-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:idiopathic-parkinsons-disease":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,52],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100657388","phase-1-assessment-of-the-safety-immunogenicity-and-pharmacodynamics-of-trb-001-in-patients-with-early-idiopathic-parkinsons-disease-100657388",false,"NCT07840027","Assessment of the Safety, Immunogenicity, and Pharmacodynamics of TRB-001 in Patients With Early Idiopathic Parkinson's Disease","A Randomized, Placebo-controlled, Double-blind, Dose-finding Phase 1b Study to Assess the Safety, Immunogenicity and Pharmacodynamics of TRB-001 in Early Idiopathic Parkinson's Disease Patients","Inclusion Criteria:\n\n1. Female or male patients aged 40-75 years old. Refer to section 5.3 for reproductive criteria for male and female participants\n2. Diagnosed with idiopathic PD within the previous 4 years based on the MDS-PD criteria. The diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity or postural instability not caused by primary visual, vestibular, cerebellar, or proprioceptive dysfunction) being present\n3. Severity ≤2 in the modified Hoehn and Yahr scale\n4. Brain magnetic resonance imaging (MRI) results should be consistent with the diagnosis of PD\n5. If on symptomatic PD medications (L-DOPA (+\u002F- benserazide, carbidopa), COMT inhibitors (entacapone, opicapone), dopamine agonists (pramipexol, ropinirole, rotigotine, apomorphine), MAO-B inhibitors (safinamid, selegiline, rasagiline) or NMDA receptor antagonists (amantadine)), doses must be stable for at least 3 months before study entry\n6. Understands and agrees to comply with the study procedures and provides written informed consent\n\nExclusion Criteria:\n\n1. Known or suspected allergy, or history of anaphylaxis, to vaccines or their excipients, or kanamycin, if considered relevant by the investigator\n2. Presence or history of autoimmune disease or immunodeficiency, if considered relevant by the investigator\n3. Presence of active infectious disease (hepatitis B, hepatitis C, or human immunodeficiency virus (HIV))\n4. Significant cognitive impairment or clinical dementia, or a Montreal Cognitive Assessment (MoCA) score \\\u003C26\n5. High suspicion of other parkinsonian syndromes, such as multiple system atrophy, progressive supranuclear palsy, drug induced Parkinsonism and post-encephalitic Parkinsonism\n6. Any relevant systemic illness. This includes cardiovascular, hepatic, gastroenterological, respiratory, endocrinological, hematologic disease, or any other condition that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study, unless patient has been on stable doses of medication for any of these concurrent illnesses for at least 3 months prior to study entry\n7. Unstable psychiatric illness, including psychosis, suicidal ideation, untreated major depression, schizophrenia, or bipolar affective disorder within 90 days before Visit 1, as determined by the investigator\n8. History of drug or alcohol abuse within the past 5 years\n9. Recent history (≤2 years) of cancer (exceptions: basal cell carcinoma, intraepithelial cervical neoplasia)\n10. Contraindication for MRI or lumbar puncture\n11. Female patients who are pregnant or lactating\n12. Birthmarks, tattoos, wounds, or skin conditions that may obscure the assessment of injection site reactions\n13. Participation in the active treatment phase of any non-PD clinical trial within 30 days prior to Visit 1\n14. Prior treatment with experimental immunotherapeutics for PD, immunosuppressive drugs or treatment with deep brain stimulation. Patient has received or plans to receive any vaccine other than study intervention within 28 days before or 28 days after each study vaccination.\n15. Employee at the study site, spouse\u002Fpartner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor","ALL","40 Years","75 Years",{"count":20,"type":21},36,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","This is a randomized, placebo-controlled, double-blind, dose-finding phase 1b study with the purpose to assess the safety, immunogenicity and pharmacodynamics of TRB-001 in early idiopathic Parkinson's Disease patients.",[27,28],"Parkinson Disease (PD)","Idiopathic Parkinson's Disease",[30,31,32,33,34,35,36,37,38],"Early idiopathic Parkinson's Disease","Randomized Study","Placebo-controlled","double-blind","dose-finding","Phase 1b","immunogenicity","pharmacodynamics","Safety","RECRUITING","2026-09-18",{"date":42,"type":43},"2026-09-24","ACTUAL",{"date":45,"type":21},"2026-09",{"date":47,"type":21},"2028-09",{"name":49,"class":50},"Tridem Bioscience FlexCo","INDUSTRY",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":16,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":22,"phases":63,"briefSummary":64,"conditions":65,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":4},"100446482","phase-1-evaluating-safety-tolerability-and-efficacy-of-autologous-mitocell-transplantation-in-subjects-with-idiopathic-parkinsons-disease-100446482","NCT05094011","Evaluating Safety, Tolerability, and Efficacy of Autologous MitoCell Transplantation in Subjects With Idiopathic Parkinson's Disease","A Phase I Open-Label Dose-Escalation Study to Evaluate the Safety, Tolerability, and Efficacy of Autologous MitoCell (Adipose-Derived Mesenchymal Stem Cells) Transplantation in Subjects With Idiopathic Parkinson's Disease","Inclusion Criteria:\n\n* Provision of signed and dated informed consent form\n* Aged 45 to 70 years old (inclusive) at Screening\n* Idiopathic Parkinson's disease patients who meet the diagnostic criteria of the \"Movement Disorder Society Clinical Diagnostic Criteria for Parkinson's disease\"\n* With at least 5 years since the diagnosis of Parkinson's disease\n* With responsiveness to levodopa or dopa agonist. This is defined as improvement between ''Off'' and ''On'' MDS-UPDRS by at least 33% of the Motor MDS-UPDRS\n* Idiopathic Parkinson's disease of Stage 3 \\~ 4 of modified Hoehn \\& Yahr staging during ''ON'' time\n* Stable Parkinsonian medications for at least 2 months prior to the Screening Visit\n* MRI not showing gross atrophy or any brain pathology other than PD\n* Mini-Mental State Examination (MMSE) ≧ 24\n* With score of the Beck Depression Inventory (BDI-II) \\\u003C 29 and Hamilton Rating Scale for Depression (HAM-D-17) \\\u003C 25\n\nExclusion Criteria:\n\n* Atypical or secondary Parkinsonism\n* With neurodegenerative disorders other than PD\n* Unable to receive MRI or PET scanning\n* With any concomitant disorder that would contraindicate coagulation, general anesthesia, or stereotactic neurosurgery\n* Received any other investigational agent within 4 weeks prior to Screening\n* History of intracranial surgeries or implantation of a device for Parkinson's disease 2 years prior to Screening\n* Major surgery within the previous 6 months at Screening\n* Significant cardiovascular disease, including:\n\n  * New York Heart Association (NYHA) class III or IV congestive heart failure\n  * Uncontrolled hypertension: Blood pressure \\>140\u002F90 mmHg\n  * History of serious ventricular arrhythmia\n* Malignancy within 2 years prior to Screening\n* Any diagnosis of autoimmune disease or immune compromised state and requiring systemic steroid or immunosuppressive treatment\n* Any other severe systemic disorder, including history of schizophrenia or other psychotic disorders, stroke, seizure, traumatic brain injury, or central nervous system infection, which judged by the investigator that entering the trial may be detrimental to the subject\n* Psychiatric, addictive or any other disorder that compromises ability to give a truly informed consent and perform all study assessments\n* Positive in any of the following regulatory authority-licensed screening tests:\n\n  * HIV antigen\u002Fantibody combo test\n  * Anti-HCV test\n  * Hepatitis B surface antigen (HBsAg) test\n  * Rapid plasma reagin (RPR) test\n  * HIV-1 nucleic acid test (NAT)\n  * HBV NAT\n  * HCV NAT\n* Any of the following hematologic abnormalities:\n\n  * Hemoglobin \\\u003C 9.0 g\u002FdL,\n  * ANC \\\u003C 1,500\u002FμL\n  * Platelets \\\u003C 100,000\u002FμL\n* Any of the following serum biochemistry abnormalities:\n\n  * Total bilirubin \\> 1.5 × ULN\n  * AST or ALT \\> 2.5 × ULN\n  * r-GT \\> 2.5 × ULN\n  * ALP \\> 2.5 × ULN\n  * serum albumin \\\u003C 3.0 g\u002FdL\n  * creatinine \\> 1.5 × ULN\n* Female subject who is lactating or has positive serum or urine pregnancy test at Screening Visit\n* Female subject with childbearing potential or male subject with female spouse\u002Fpartner with childbearing potential who refuses to adopt at least two forms of birth control (at least one of which must be a barrier method) from Screening until Final\u002FEarly Termination Visit. Acceptable forms include:\n\n  * Established use of oral, injected or implanted hormonal methods of contraception\n  * Placement of an intrauterine device (IUD) or intrauterine system (IUS)\n  * Barrier methods of contraception: condom, or occlusive cap (diaphragm or cervical\u002Fvault caps)\n* With any condition judged by the investigator that entering the trial may be detrimental to the subject","45 Years","70 Years",{"count":62,"type":21},9,[24],"Primary Objective: To assess the safety profile of autologous MitoCell administered to subjects with idiopathic Parkinson's disease (PD)\n\nSecondary Objective: To explore the efficacy and safety of MitoCell given as the recommended dose by stereotactic intrastriatal implantation",[28],"NOT_YET_RECRUITING","2024-11-18",{"date":69,"type":43},"2024-11-21",{"date":71,"type":21},"2026-03-01",{"date":73,"type":21},"2028-07-31",{"name":75,"class":50},"Taiwan Mitochondrion Applied Technology Co., Ltd."]