[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582049":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":31,"centralContacts":35,"locations":30,"responsibleParty":45,"collaborators":48,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":30,"studyType":65,"phases":66,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":80,"whyStopped":30,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":30},{"fullName":5,"class":6},"Apeiron Research Center","OTHER",[8,14,17,21],{"label":9,"type":10,"description":11,"interventionNames":12},"Parkinson Disease Group 1","EXPERIMENTAL","Day 0 - Sham IV + INA BMAC 6 months - IV BMA + Sham INA 12 months - IV BMA + INA BMAC",[13],"Biological: Autologous mesenchymal stem cells",{"label":15,"type":10,"description":11,"interventionNames":16},"Parkinson Plus Syndrome Group 1",[13],{"label":18,"type":10,"description":19,"interventionNames":20},"Parkinson Disease Group 2","Day 0 - IV BMA + Sham INA 6 months - Sham IV + INA BMAC 12 months - IV BMA + INA BMAC",[13],{"label":22,"type":10,"description":19,"interventionNames":23},"Parkinson Plus Syndrome Group 2",[13],[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","Autologous mesenchymal stem cells","1. Participant's blood is drawn at the start of each visit.\n2. Bone marrow aspirate is drawn from the posterior aspect of the pelvis and is subsequently harvested and processed.\n3. The following procedures are administered in a crossover design (Day 0 and 6 months):\n\n   * Intranasal bone marrow aspirate administration (INA BMAC) OR Sham INA\n   * Intravenous bone marrow aspirate administration (IV BMA) OR Sham IVA\n4. At 12 months, all participants receive IV BMA + INA BMAC",[9,18,15,22],null,[32],{"name":33,"affiliation":5,"role":34},"Jason Glowney, MD, MSc","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":30,"email":40},"Jenna Zajac, PT, DPT, PhD","CONTACT","720-593-7595","jzajac@apeironresearch.org",{"name":42,"role":38,"phone":43,"phoneExt":30,"email":44},"Robert Pickels, MS","720-583-5047","rpickels@apeironresearch.org",{"type":34,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Jason Glowney","Principal Investigator\u002FMedical Director",[49],{"name":50,"class":6},"University of Colorado, Boulder","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":63,"type":64},60,"ESTIMATED","INTERVENTIONAL",[67,68],"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.",[71,72],"Atypical Parkinsonism","Parkinson Disease (PD)",[71,74,75,76,77,78,79],"Parkinson-Plus Syndrome","Stem Cells","MSCs","Epigenetics","Metagenomics","Parkinson's Disease","NOT_YET_RECRUITING","2025-02-27",{"date":83,"type":84},"2025-03-05","ACTUAL",{"date":86,"type":64},"2025-04-01",{"date":88,"type":64},"2028-04",{"name":5,"class":6}]