[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Apeiron Research Center\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":50},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":4},"100582049","phase-1-standard-optimization-of-stem-cells-in-parkinsons-disease-and-atypical-parkinsonism-100582049",false,"NCT06858254","Standard Optimization of Stem Cells in Parkinson's Disease and Atypical Parkinsonism","Standard Optimization of Autologous Stem Cells by Intranasal and Intravenous Administration to Treat Parkinson's Disease and Atypical Parkinsonism","SO-ASC-INIVAT","General Inclusion Criteria:\n\n* Participants aged 40-75 years old with a diagnosis of PD or PPS (DLB, PSP, MSA, CBD with parkinsonism) based upon clinical criteria and standardized testing\n* Participants time of documented PD or PPS is \\\u003C\u002F= 6 years\n* Participants with an anticipated survival of at least 3 years in the investigator's opinion\n* Participants who are willing and able to give informed consent\n* Participants who can comply with the study protocol over the 18-month duration\n* Stable medical profile for 60 days prior to the initial intake screening\n* Participants can ambulate at least 25m without assistance\n* No known history of heparin-induced thrombocytopenia\n\nPD Inclusion Criteria:\n\n* Idiopathic Parkinson's disease patients who meet the MDS's Clinical Diagnostic Criteria for Parkinson's disease\n* Responsive to levodopa or dopamine agonists defined by \\>\u002F= 33% improvement in \"Off\"\u002F\"On\" symptoms by MDS-UPDRS-III\n* A modified Hoehn and Yahr stage of \\\u003C\u002F= 3\n* Neuroimaging findings are consistent with PD and absent of atrophy or other brain pathology inconsistent with PD\n* \"Normal\" cognition as assessed by Montreal Cognitive Assessment (MoCA), with a value \\>\u002F= 26\n\nPPS Inclusion Criteria:\n\nDLB -\n\n* High probability of cognitive capacity to give informed consent by the Montreal Cognitive Assessment (MoCA), with a value \\>\u002F= 23\n* Probable DLB - DLB consortium: Two or more core clinical features are present (including features of parkinsonism for the study), or only one core clinical feature is present, but with one or more indicative biomarkers\n* Core clinical features:\n\n  * Fluctuating cognition with pronounced variations in attention and alertness\n  * Recurrent visual hallucinations that are typically well-formed and detailed Rapid eye movement (REM) sleep behavior disorder (RBD), which may precede cognitive decline\n* One or more spontaneous cardinal features of parkinsonism: bradykinesia, resting tremor, or rigidity\n* Indicative biomarkers:\n\n  * Reduced dopamine transporter uptake in basal ganglia demonstrated by SPECT\u002FPET\n  * Abnormal (low uptake) I-MIBG myocardial scintigraphy\n  * Polysomnographic confirmation of REM sleep without atonia\n\nPSP -\n\n* MDS Diagnostic Criteria for probable PSP with predominant parkinsonism (PSP-P)\n* Ocular motor dysfunction: vertical supranuclear gaze palsy or slow velocity of vertical saccades or frequent macro square wave jerks (\"eyelid-opening apraxia\")\n* Ocular motor dysfunction + akinetic-rigid, axial predominant, levodopa resistant or with tremor and\u002For asymmetric and\u002For levodopa responsive (akinesia)\n* \"Normal\" cognition as assessed by Montreal Cognitive Assessment (MoCA), with a value \\>\u002F= 26\n\nMSA -\n\n* MDS Diagnostic Criteria for clinically probable MSA\n* Autonomic dysfunction\n* Parkinsonism\n* Cerebellar syndrome, including at least one of gait ataxia, limb ataxia, cerebellar dysarthria, or oculomotor features\n* \"Normal\" cognition as assessed by Montreal Cognitive Assessment (MoCA), with a value \\>\u002F= 26\n\nCBD -\n\n* Chronic progressive course\n* Asymmetric onset\n* Higher cortical dysfunction: apraxia, speech apraxia, non-fluent aphasia, alien limb phenomena, or cortical sensory loss\n* Movement disorder: rigid\u002Fakinetic syndrome and either dystonic limb posturing or focal myoclonus in limb, and levodopa resistant\n* \"Normal\" cognition as assessed by Montreal Cognitive Assessment (MoCA), with a value \\>\u002F= 26\n\nExclusion Criteria:\n\n* Other non-PD\u002FPPS Parkinsonism (e.g., drug-induced, vascular parkinsonism)\n* No strong familial history of PD\u002FPPS not attributable to environmental exposure or any known genetic predisposition to PD\u002FPPS\n* Unable to receive\u002Ftolerate neuroimaging (e.g., MRI-incompatible cardiac pacemaker)\n* Unable to maintain\u002Ftolerate supine position with cervical neck extension\n* Active systemic infection or local infection near the lumbar pelvis region\n* Any bone marrow aspiration from the pelvis within 6 months of initial screening\n* Any musculoskeletal-pelvis contraindications to BMA harvest from the PSIS\n* Concurrent enrollment in another PD\u002FPPS study or having taken\u002Freceived another investigational intervention within 6 weeks of initial screening\n* Malignancy diagnosed \\\u003C\u002F= 2 years prior to initial screening\n* History of intracranial or nasopharyngeal surgery deemed detrimental to the participant during the trial, including brain surgery\u002Fstereotactic procedure for PD\u002FPPS\n* History of electroconvulsive therapy\n* Chronic Kidney Disorder (CKD) \\> Stage II or eGFR \\\u003C60 mL\u002Fmin\n* Autoimmune disease, including:\n\n  * Rheumatoid Arthritis (RA)\n  * Systemic Lupus Erythematosus (SLE)\n* Any disorders of glucocorticoid excess or diseases requiring systemic steroids or immune-modulating therapies\n* Cardiac disease deemed significant:\n\n  * Poorly controlled hypertension (BP \\>\u002F=140\u002F90)\n  * NYHA class III or IV congestive heart failure\n  * History of a significant ventricular arrhythmia\n* Obesity class II or higher (BMI \\>\u002F= 35)\n* Moderate-to-uncontrolled diabetes HbA1c \\>\u002F= 7%\n* Osteoporosis\n* A history of other severe systemic disorders, including significant CVA, TBI, seizure, encephalitis, meningitis, or psychiatric disorder that is deemed potentially harmful to the participant by the PI\n* Positive for HIV, HBV, HCV, or syphilis\n* Any of the following lab abnormalities:\n\n  * Hematology: Hgb \\\u003C 10 g\u002Fdl, ANC \\\u003C 1.550\u002FL, platelets \\\u003C 100,000 \u002FL \\>Chemistry: albumin \\\u003C 3.0 g\u002FdL, serum creatine \\> 1.5 x ULN, total bilirubin \\> 1.5 x ULN, AST\u002FALT\u002FALP \\> 2.0 x ULN\n* Female or another gender with childbearing potential not willing to adopt barrier method(s) of contraception, plus one other form, including:\n\n  * Intrauterine system (IUS)\n  * Intrauterine device (IUD)\n  * Oral, injected, or implanted hormonal contraception\n* Female or another gender who is lactating\u002Fbreastfeeding or has a positive urine or serum pregnancy test at intake screening\n* Any disorder that compromises the participant's ability to give appropriate informed consent or hinders the ability to perform the assessment and receive the study's interventions\n* Any other condition not listed above that is deemed potentially harmful to the participant by the PI","ALL","40 Years","75 Years",{"count":21,"type":22},60,"ESTIMATED","INTERVENTIONAL",[25,26],"PHASE1","PHASE2","The purpose of this study is to measure outcomes using intranasal and intravenous autologous bone marrow mesenchymal stem cells (BM-MSCs) for Parkinson Disease (PD) and Parkinson's Plus (PPS) patients.",[29,30],"Atypical Parkinsonism","Parkinson Disease (PD)",[29,32,33,34,35,36,37],"Parkinson-Plus Syndrome","Stem Cells","MSCs","Epigenetics","Metagenomics","Parkinson's Disease","NOT_YET_RECRUITING","2025-02-27",{"date":41,"type":42},"2025-03-05","ACTUAL",{"date":44,"type":22},"2025-04-01",{"date":46,"type":22},"2028-04",{"name":48,"class":49},"Apeiron Research Center","OTHER",""]