protocolSection identificationModule nctId: NCT06344026, orgStudyIdInfo id: ANPD001-02, briefTitle: Phase 1/2a Study of ANPD001 in Parkinson Disease, acronym: ASPIRO, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-23, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2030-04-30, studyFirstPostDateStruct date: 2024-04-03, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Aspen Neuroscience, class: INDUSTRY, collaborators name: California Institute for Regenerative Medicine (CIRM), descriptionModule briefSummary: This clinical trial is designed to test the safety and tolerability of injecting ANPD001 cells that will mature into dopamine-producing cells into the brain of participants with Parkinson Disease. All participants will have ANPD001 cells manufactured from their own previously collected cells., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: Open label, dose escalation of bilateral injection of ANPD001 dopaminergic precursor cells to the putamen, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 9, type: ESTIMATED, armsInterventionsModule interventions name: ANPD001, interventions name: Custom Device, outcomesModule primaryOutcomes measure: Incidence and severity of treatment emergent adverse events (Safety and Tolerability), secondaryOutcomes measure: "ON" time without troublesome dyskinesia, secondaryOutcomes measure: Post-injection change in Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II (Activities of Daily Living - ADL) and Part III (motor score) in the ON state (total score and scores for Parts I-IV), secondaryOutcomes measure: Post-injection change in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III score in the practically defined OFF state, secondaryOutcomes measure: Post-injection change in the 18F-DOPA uptake in the putamen, secondaryOutcomes measure: Incidence and severity of treatment emergent adverse events during long term follow-up (Continued Safety and Tolerability), eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Arizona - Banner Health, city: Tucson, state: Arizona, zip: 85724, country: United States, geoPoint lat: 32.22174, lon: -110.92648, locations facility: Scripps Health, city: La Jolla, state: California, zip: 92037, country: United States, geoPoint lat: 32.84727, lon: -117.2742, locations facility: University of California, Irvine, city: Orange, state: California, zip: 92868, country: United States, geoPoint lat: 33.78779, lon: -117.85311, locations facility: University of California, San Francisco, city: San Francisco, state: California, zip: 94143, country: United States, geoPoint lat: 37.77493, lon: -122.41942, locations facility: Feinstein Institutes, city: Manhasset, state: New York, zip: 11030, country: United States, geoPoint lat: 40.79788, lon: -73.69957, hasResults: False