[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643725":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":26,"responsibleParty":42,"collaborators":10,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":48,"sex":54,"minAge":55,"maxAge":10,"enrollmentInfo":56,"targetDuration":10,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":10,"overallStatus":29,"whyStopped":10,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":74},{"fullName":5,"class":6},"IRCCS San Raffaele","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Multiple Sclerosis patients treated with autologous HSCT as standard of care",null,"The study will involve 20 Multiple Sclerosis (MS) patients, treated with autologous HSCT as standard-of-care according to guidelines and consensus recommendations. Autologous Hematopoietic stem cell transplantation (HSCT) is considered a standard-of-care intervention in the following selected MS patients: RRMS who have failed to respond to one or more high-efficacy Disease modifying therapies (DMTs) or progressive MS with superimposed inflammatory activity, or aggressive forms of MS where rapid neurological decline occurs early in the disease course.",[13],"Drug: ATLG administration",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DRUG","ATLG administration","Patients will receive standard conditioning regimen (BEAM or cyclophosphamide) and ATLG (total dose 30 mg\u002Fkg over 3 days: 10 mg\u002Fkg on days -3, -2 and -1).",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Raffaella Greco","CONTACT","+39 02-2643-3903","greco.raffaella@hsr.it",[27],{"facility":28,"status":29,"city":30,"state":31,"zip":32,"country":31,"countryCode":33,"cosmosGeoPoint":34,"geoPoint":39,"contacts":40},"IRCCS Ospedale San Raffaele","RECRUITING","Milan","Italy","20132","IT",{"type":35,"coordinates":36},"Point",[37,38],12.59836,42.78235,{"lat":38,"lon":37},[41],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},{"type":43,"investigatorFullName":44,"investigatorTitle":45,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Ciceri Fabio","Professor","100643725","atlg-levels-in-autologous-hsct-for-multiple-sclerosis-100643725",false,"NCT07635693","ATLG Levels in Autologous HSCT for Multiple Sclerosis","ATLG Levels and Immune Reconstitution Kinetics in Autologous HSCT for Multiple Sclerosis","ATLG-MS","Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the study.\n* Adult patients (age \\>\u002F= 18y)\n* Diagnosis of MS\n* Confirmed program of autologous HSCT according to standard EBMT indications (any conditioning regimen considered standard, BEAM or Cyclophosphamide)\n* ATLG (total dose 30 mg\u002Fkg over 3 days: 10 mg\u002Fkg on days -3, -2 and -1) in the conditioning regimen.\n\nExclusion Criteria:\n\n* Subjects that did not accept to sign the informed consent.\n* Use of ATG.\n* Contraindications to HSCT procedures (including pregnancy and breast feeding, uncontrolled active infections)","ALL","18 Years",{"count":57,"type":58},20,"ESTIMATED","OBSERVATIONAL","This is a prospective, observational, biological, multicenter study to investigate IR profile, ATLG dynamics, main HSCT and disease outcomes in MS. This study will provide a preliminary descriptive evaluation of key study parameters, including ATLG pharmacokinetics and immune reconstitution trends, as well as an initial assessment of variability (e.g., dispersion of immunological biomarkers), to support the interpretation of results and the design of future studies. Since this is an observational study, no clinical decision will be made, and the interim analysis will not have an impact of the study conduction, and it will not be a stopping rule.",[62,63,64],"Multiple Sclerosis","Autologous Hematopoietic Stem Cell Transplant","ATLG","2026-06-04",{"date":67,"type":68},"2026-06-09","ACTUAL",{"date":70,"type":68},"2026-05-04",{"date":72,"type":58},"2029-05-04",{"name":44,"class":6},1]