[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100441512":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":36,"responsibleParty":56,"collaborators":31,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":31,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":31,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":31,"overallStatus":38,"whyStopped":31,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Children's Hospital of Philadelphia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"CD3\u002FCD19 depleted ASCT","EXPERIMENTAL","The test article is autologous stem cell transplant with a CD3\u002FCD19-depleted stem cell product.",[13],"Biological: Depletion of CD3\u002FCD19 in an autologous stem cell transplant",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Depletion of CD3\u002FCD19 in an autologous stem cell transplant","The purpose of this study is to determine the safety and feasibility of CD3\u002FCD19 depleted autologous stem cell transplant for the treatment of life threatening autoimmune disease. We will perform CD3\u002FCD19 depletion using the CliniMACs device as a means of purging autoreactive T and B cells from the transfused autologous stem cell product, while retaining some immune function, namely natural killer cells and monocytes in the product.",[9],[21],"CD3\u002FCD19 depletion using cliniMACs device",[23],{"name":24,"affiliation":5,"role":25},"Caitlin Elgarten, MD","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Patricia M Hankins","CONTACT","(215) 590-5168",null,"HANKINSP@chop.edu",{"name":24,"role":29,"phone":34,"phoneExt":31,"email":35},"2158079038","elgartenc@chop.edu",[37],{"facility":5,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Philadelphia","Pennsylvania","19104","United States","US",{"type":45,"coordinates":46},"Point",[47,48],-75.16362,39.95238,{"lat":48,"lon":47},[51,53,55],{"name":52,"role":29,"phone":30,"phoneExt":31,"email":32},"Study Coordinator",{"name":54,"role":29,"phone":34,"phoneExt":31,"email":35},"Principal investigator",{"name":24,"role":25,"phone":31,"phoneExt":31,"email":31},{"type":57,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"SPONSOR_INVESTIGATOR","Stephan Grupp MD PhD","Director of Cancer Immunotherapy Program","100441512","phase-2-autologous-stem-cell-transplant-asct-for-autoimmune-diseases-100441512",false,"NCT05029336","Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases","Autologous Hematopoietic Stem Cell Transplant for Children and Young Adults With Life Threatening Autoimmune Diseases","Inclusion Criteria:\n\n1. Age 8 ≤ 25 years at time of enrollment.\n2. Severe systemic sclerosis or systemic lupus erythematosus based on specific criteria\n3. Adequate organ function status\n4. No active, untreated infections.\n\nExclusion Criteria:\n\n1. Previous hematopoietic stem cell transplant (HSCT) or solid organ transplant\n2. Pregnancy\n3. Ongoing participation in a clinical trial testing an investigational drug or ongoing receipt of disallowed disease modifying anti-rheumatic drugs (DMARD)\n4. Severe comorbidity that jeopardizes the ability of the subject to tolerate therapy","ALL","8 Years","25 Years",{"count":71,"type":72},20,"ESTIMATED","INTERVENTIONAL",[75],"PHASE2","A subset of autoimmune diseases (ADs) in children and young adults are life-threatening and unresponsive to conventional treatments. In these patients, the delivery of high dose immunosuppressive therapy followed by autologous stem cell transplant (ASCT) offers a treatment strategy capable of purging the pathogenic, autoreactive immune system and an opportunity for \"immune reset.\" This strategy has been used in adults across a myriad of indications with evidence for efficacy. This study proposes a pilot study to evaluate this therapeutic strategy in children and young adults with systemic sclerosis (SSc) and systemic lupus erythematosis (SLE), two potentially life threatening autoimmune diseases that may response to this therapeutic approach.",[78,79],"Systemic Lupus Erythematosus","Systemic Sclerosis","2025-10-09",{"date":82,"type":83},"2025-10-14","ACTUAL",{"date":85,"type":72},"2026-03",{"date":87,"type":72},"2031-05",{"name":58,"class":6},1]