[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621222":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":46,"locations":56,"responsibleParty":72,"collaborators":27,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":80,"eligibilityCriteria":81,"healthyVolunteers":76,"sex":82,"minAge":83,"maxAge":84,"enrollmentInfo":85,"targetDuration":27,"studyType":88,"phases":89,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":58,"whyStopped":27,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"University Hospital, Toulouse","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"50 millions AdMSC dose","EXPERIMENTAL","Allogeneic AdMSC (CellREADY® drug product), intravenous administration, dose of 50x106 or 100x106 AdMSC (from 3 to 6 patients, \"50x106 AdMSC \" group, group 1)",[13,14,15],"Drug: CellREADY® drug product IV dose of 50 millions","Diagnostic Test: cerebral RMI","Diagnostic Test: PET scan",{"label":17,"type":10,"description":18,"interventionNames":19},"100 millions AdMSc dose","Allogeneic AdMSC (CellREADY® drug product), intravenous administration, dose of 50x106 or 100x106 AdMSC (from 3 to 6 patients, \"100x106 AdMSC \" group, group 2) if safety analysis of group 1 is correct.",[20,14,15],"Drug: CellREADY® drug product IV dose of 100 millions",[22,28,32,37],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","CellREADY® drug product IV dose of 50 millions","Allogeneic AdMSC (CellREADY® drug product), intravenous administration, dose of 50 millions.\n\nInitially, 3 patients will receive the lowest dose (50x106 AdMSC). If the safety analysis of the first 3 patients infused at dose 50x106 AdMSC does not show clinically significant AEs after 6 months of follow-up, 100x106 AdMSC administration may be started in 3 new patients. On the other hand, if safety analysis of the first 3 patients shows a clinically significant AE, 3 new patients will be injected at this same dose before making a final decision on the possibility of dose escalation. Thus, the \"100x106 AdMSC \" group will only start after the 6-month follow-up and safety analysis completed in the \"50x106 AdMSC \" group. For each dose, all patients will be followed for 6 months post-injection with 6 visits.",[9],null,{"type":23,"name":29,"description":30,"armGroupLabels":31,"otherNames":27},"CellREADY® drug product IV dose of 100 millions","Allogeneic AdMSC (CellREADY® drug product), intravenous administration, dose of 100 millions.\n\nInitially, 3 patients will receive the lowest dose (50x106 AdMSC). If the safety analysis of the first 3 patients infused at dose 50x106 AdMSC does not show clinically significant AEs after 6 months of follow-up, 100x106 AdMSC administration may be started in 3 new patients. On the other hand, if safety analysis of the first 3 patients shows a clinically significant AE, 3 new patients will be injected at this same dose before making a final decision on the possibility of dose escalation. Thus, the \"100x106 AdMSC \" group will only start after the 6-month follow-up and safety analysis completed in the \"50x106 AdMSC \" group. For each dose, all patients will be followed for 6 months post-injection with 6 visits.",[17],{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"DIAGNOSTIC_TEST","cerebral RMI","cerebral RMI at V1, V5 and V6",[17,9],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":27},"PET scan","amyloïde PET scan (flutémétamol) at V1 and V6",[17,9],[42],{"name":43,"affiliation":44,"role":45},"Julien DELRIEU, MD_PH","University Hospital of Toulouse","PRINCIPAL_INVESTIGATOR",[47,53],{"name":48,"role":49,"phone":50,"phoneExt":51,"email":52},"Julien DELRIEU, MD-PH","CONTACT","05 61 77 70 58","+33","delrieu.j@chu-toulouse.fr",{"name":54,"role":49,"phone":27,"phoneExt":27,"email":55},"Delphine Pennetier","pennetier.d@chu-toulouse.fr",[57],{"facility":44,"status":58,"city":59,"state":27,"zip":27,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"RECRUITING","Toulouse","France","FR",{"type":63,"coordinates":64},"Point",[65,66],1.44367,43.60426,{"lat":66,"lon":65},[69,71],{"name":70,"role":49,"phone":27,"phoneExt":27,"email":27},"Julien DELRIEU, PU-PH",{"name":70,"role":45,"phone":27,"phoneExt":27,"email":27},{"type":73,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100621222","phase-1-allogeneic-adipose-tissue-derived-stem-cells-in-alzheimer-disease-100621222",false,"NCT07367815","Allogeneic Adipose Tissue Derived-stem Cells in Alzheimer Disease","Allogeneic Intraveinous Injection of Adipose Tissue Derived-mesenchymal Stem Cells in Mild to Moderate Alzheimer Disease: a Phase I\u002FII Trial","A3D","Inclusion Criteria:\n\n* Patient between 50 and 85 years old\n* AD diagnosis according to NIA-AA 2011 criteria at a mild to moderate stage :\n\nMMSE score between 14 and 26 (include) positive AD amyloid biomarker\n\n* CDR (clinical dementia rating) score ≥ 1\n* Patient with no absolute contraindications for PET or MRI scans\n* Consent signed by the patient and study partner\n* presence of primary caregiver\n* Patient with social security coverage\n\nExclusion Criteria:\n\n* Brain disease (other than AD) that may cause dementia\n* Presence of concomitant pathologies not permitting participation in the study\n* Concurrent participation in other research that may influence the testing of the A3D study\n* Carrier of a pacemaker, valve prosthesis or other internal magnetic or electronic system, history of neurosurgery or aneurysm surgery, presence of metal fragments in the eyes, brain or marrow, claustrophobia\n* PET scan performed in the previous year (research context)\n* History of cancer diagnosed within the last 5 years\n* Presence of \\> 4 brain microbleeds, a single area of superficial siderosis, or evidence of previous macrohaemorrhage assessed by brain MRI scan\n* Regular use of corticosteroids or other steroidal anti-inflammatory drugs (e. g. prednisone)\n* Presence of an autoimmune disease (e. g. rheumatoid arthritis, systemic lupus erythematosus) with the exception of psoriasis\n* Pregnant or breastfeeding woman\n* Adults under guardianship or other legal protection, deprived of their liberty by judicial or administrative decision For patients who will participate in the optional adipose puncture (only carried out in the Toulouse center): Antithrombotic treatment and xylocaine allergy are prohibited.","ALL","50 Years","85 Years",{"count":86,"type":87},9,"ESTIMATED","INTERVENTIONAL",[90,91],"PHASE1","PHASE2","A3D is a phase I\u002FII clinical trial. The primary objective is to evaluate the safety of allogeneic adipose tissue derived-stem cells (AdMSC) administered by intravenous (IV) route in mild to moderate Alzheimer disease (AD) using a dose escalation protocol.",[94],"Alzheimer Disease",[96,97,98,99,100],"Alzheimer disease,","phase I\u002FII,","safety,","mesenchymal stem cell,","adipose tissue","2026-06-18",{"date":103,"type":104},"2026-06-23","ACTUAL",{"date":106,"type":104},"2026-05-07",{"date":108,"type":87},"2029-05-01",{"name":5,"class":6},1]