[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Craig van Horne, MD, PhD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":72},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100568602","phase-1-autologous-sural-nerve-grafting-to-the-substantia-nigra-in-patients-with-synuclienopathies-100568602",false,"NCT06683365","Autologous suraL nervE Grafting to the Substantia nigrA in Patients With Synuclienopathies","A Phase I Study of the Feasibility and Safety of SuraL nervE Tissue Grafting to the Substantia nigrA in Patients With Synucleinopathies (LEAP)","LEAP","Inclusion Criteria:\n\n* Diagnosis of clinically established or clinically probable PD or MSA as defined by MDS criteria\n* Disease duration greater than 2 years\n* Age 40-75, inclusive\n* MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Part III greater than or equal to 20 points but less than or equal to 35 points, off anti-parkinsonian medication for PD or MDS-Unified Multiple System Atrophy Rating Scale (UMSARS) less than or equal to 30 points off anti-parkinsonian medication\n* No MDS-UPDRS Part III score \\>3 on items 3.3, 3.4, 3.5, 3.6, 3.7, 3.8, 3.14 while off medication\n* Able and willing to undergo ioflupane\u002FSPECT\n* Able to tolerate the surgical procedure\n* Able to undergo all planned assessments\n* Available access to the sural nerve\n\nExclusion Criteria:\n\n* Previous PD surgery or intracranial surgery\n* Ongoing major medical or psychiatric disorder incl. depression and psychosis\n* Other concomitant treatment with neuroleptics\n* Typical, nonparkinsonian syndrome ioflupane\u002FSPECT signal\n* Unable to undergo an MRI\n* An obstructed trajectory path to the substantia nigra\n* Significant microvascular disease\n* Use of anticoagulants other than aspirin\n* Female who is pregnant, lactating, or of child-bearing potential unwilling to use an adequate birth control method during the period of the study\n* Consent capacity will be assessed and determined during and throughout a participant's neuropsychological exam. A participant who experiences a decline in consent capacity prior to surgery, will be removed from the study by the PI. A decline in consent capacity after surgery will not result in the removal of the participant in the study.","ALL","40 Years","75 Years",{"count":21,"type":22},7,"ESTIMATED","INTERVENTIONAL",[25],"PHASE1","This phase I double-blind study focuses on the safety and feasibility of implanting autologous peripheral nerve tissue (PNT) into the substantia nigra area of the brain in persons who have been diagnosed with either Parkinson's disease (PD) or Multiple System Atrophy (MSA). 7 participants will be enrolled, with 4 participants receiving the graft and 3 receiving a sham surgery. Eligible participants will be early in their diagnosis with a lower burden of symptoms. Participants will be followed initially for one year after surgery.",[28,29],"Multiple System Atrophy","Parkinsons Disease",[31,32,28,29],"Synucleinopathies","Cell and Tissue Based Therapy","RECRUITING","2026-03-26",{"date":36,"type":37},"2026-04-01","ACTUAL",{"date":39,"type":37},"2025-02-25",{"date":41,"type":22},"2030-12-02",{"name":43,"class":44},"Craig van Horne, MD, PhD","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":17,"minAge":54,"maxAge":19,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":45},"100568603","phase-1-a-study-to-evaluate-feasibility-safety-and-clinical-responses-of-implanting-autologous-peripheral-nerve-tissue-into-the-brain-for-non-motor-or-motor-symptoms-in-patients-with-parkinsons-disease-undergoing-dbs-surgery-100568603","NCT06683378","A Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Brain for Non-motor or Motor Symptoms in Patients With Parkinson's Disease Undergoing DBS Surgery","Phase I Randomized, Double-blind Study to Evaluate Feasibility, Safety, and Clinical Responses of Implanting Autologous Peripheral Nerve Tissue Into the Nucleus Basalis of Meynert or Substantia Nigra for Non-motor or Motor Symptoms in Patients With Parkinson's Disease Undergoing DBS Surgery","STAR","Inclusion Criteria:\n\n* Undergoing DBS\n* Diagnosis of clinically established or clinically probably PD as defined by MDS criteria\n* Age 45-75, inclusive\n* Able to tolerate the surgical procedure\n* Able to undergo all planned assessments\n* Available access to the sural nerve\n\nExclusion Criteria:\n\n* Any condition that would not make the subject a candidate for DBS\n* Dementia diagnosis\n* Previous PD surgery or intracranial surgery\n* Unable to undergo an MRI\n* An obstructed trajectory path to the substantia nigra and nucleus basalis of Meynert","45 Years",{"count":56,"type":22},24,[25],"The investigators propose a Phase I single surgical-center, double-blinded randomized parallel clinical trial involving bilateral autologous peripheral nerve tissue (PNT) delivery into the NBM or the alternate target also affecting cognition in this population, the substantia nigra (SN), to address \"repair cell\" support of these areas. Twenty-four participants with idiopathic Parkinson's Disease (PD) who have selected, qualified and agreed to receive as standard of care deep brain stimulation (DBS) will be enrolled and randomly allocated to receive bilateral PNT deployment to either the NBM or SN at the time of DBS surgery. Participants will be allocated equally among both assignments over the course of three years (8 Year 1, 10 Year 2, 6 Year 3). Participants will be evaluated for neurocognitive, motoric function, activities of daily living, and quality of life at enrollment before surgery, two-weeks after surgery, and 6, 12, and 24 months after surgery.",[60],"Parkinson's Disease",[60,62,63,32],"Deep Brain Stimulation","DBS","2025-08-11",{"date":66,"type":37},"2025-08-14",{"date":68,"type":37},"2025-07-21",{"date":70,"type":22},"2028-02-28",{"name":43,"class":44},""]