[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100249954":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":89,"collaborators":19,"id":91,"slug":19,"hasResults":92,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":19,"eligibilityCriteria":96,"healthyVolunteers":92,"sex":97,"minAge":98,"maxAge":19,"enrollmentInfo":99,"targetDuration":19,"studyType":102,"phases":103,"briefSummary":105,"conditions":106,"keywords":110,"overallStatus":36,"whyStopped":19,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Children's Hospital Medical Center, Cincinnati","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Viral Specific VST Infusion","EXPERIMENTAL","3rd party VST infusion",[13],"Biological: Viral Specific VST Infusion",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BIOLOGICAL","VSTs will be infused into immunocompromised patients with evidence of viral infection or reactivation defined as any of the following:\n\n* Blood adenovirus PCR ≥ 1,000\n* Blood CMV PCR ≥ 500\n* Blood EBV PCR ≥ 9,000\n* Plasma BKV PCR \\>1,000\n* Plasma JC Virus PCR \\> 1,000\n* Evidence of invasive adenovirus infection or disease, defined as the presence of adenoviral positivity by PCR or culture in one or more sites\n* Evidence of invasive CMV infection, eg pneumonitis, retinitis, colitis\n* Evidence of invasive EBV disease\u002Finfection, EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation, or EBV-associated malignancies\n* Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, or BK nephropathy\n* Evidence of PML or other CNS infection due to JC virus",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Michael Grimley, MD, MD","PRINCIPAL_INVESTIGATOR",[25,30],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Jamie Wilhelm","CONTACT","(513) 803-1102","Jamie.Wilhelm@cchmc.org",{"name":31,"role":27,"phone":19,"phoneExt":19,"email":32},"Michael Grimley, MD","Michael.Grimley@cchmc.org",[34,54,64,74],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Akron Children's Hospital","RECRUITING","Akron","Ohio","44308","United States",{"type":42,"coordinates":43},"Point",[44,45],-81.51901,41.08144,{"lat":45,"lon":44},[48,52],{"name":49,"role":27,"phone":50,"phoneExt":19,"email":51},"Courtney Culbertson, CNP","330-543-3338","cculbertson@akronchildrens.org",{"name":53,"role":23,"phone":19,"phoneExt":19,"email":19},"Megan Sampson, MD",{"facility":55,"status":56,"city":57,"state":38,"zip":58,"country":40,"cosmosGeoPoint":59,"geoPoint":63,"contacts":19},"University of Cincinnati Medical Center","COMPLETED","Cincinnati","45219",{"type":42,"coordinates":60},[61,62],-84.51439,39.12711,{"lat":62,"lon":61},{"facility":65,"status":36,"city":57,"state":38,"zip":66,"country":40,"cosmosGeoPoint":67,"geoPoint":69,"contacts":70},"Cincinnati Children's Hospital Medical Center","45229",{"type":42,"coordinates":68},[61,62],{"lat":62,"lon":61},[71,73],{"name":26,"role":27,"phone":72,"phoneExt":19,"email":29},"513-803-1102",{"name":31,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":75,"status":36,"city":76,"state":38,"zip":77,"country":40,"cosmosGeoPoint":78,"geoPoint":82,"contacts":83},"The Ohio State University Wexner Medical Center - James Cancer Hospital","Columbus","43210",{"type":42,"coordinates":79},[80,81],-82.99879,39.96118,{"lat":81,"lon":80},[84,87],{"name":85,"role":27,"phone":19,"phoneExt":19,"email":86},"Nicole Szuminski, MS, RN, CCRC","nicole.szuminski@osumc.edu",{"name":88,"role":23,"phone":19,"phoneExt":19,"email":19},"Polina Shindiapina, MD, PhD",{"type":90,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100249954",false,"NCT02532452","Third Party Viral Specific T-cells (VSTs)","Third Party Viral Specific T-cells (VSTs) for Treatment of Viral Infections in Immunocompromised Patients","Inclusion Criteria:\n\n* Immunocompromised patient with evidence of viral infection or reactivation\n* Age \\>1 day\n* Recipients who have had a stem cell transplant must be at least 21 days after stem cell infusion\n* Clinical status must allow tapering of steroids to \\\u003C 0.5mg\u002Fkg prednisone or other steroid equivalent\n* Must be able to receive CTL infusion in Cincinnati\n* Informed consent obtained by PI or sub-investigator either in person or by phone\n\nExclusion Criteria:\n\n* Active acute GVHD grades II-IV\n* Uncontrolled bacterial or fungal infection\n* Uncontrolled relapse of malignancy requiring treatment with chemotherapy\n* Infusion of ATG or alemtuzumab within 2 weeks of VST infusion\n* Biopsy confirmed acute rejection of solid organ transplant OR empiric treatment of suspected but not confirmed acute rejection of solid organ transplant within the last 30 days","ALL","2 Days",{"count":100,"type":101},750,"ESTIMATED","INTERVENTIONAL",[104],"PHASE2","The purpose of this study is to demonstrate that viral specific T-cells (a type of white blood cell) can be generated from an unrelated donor and given safely to patients with viral infections.",[107,108,109],"Viral Infection","Viral Reactivation","Infection in an Immunocompromised Host",[111,112,113,114,115,116],"Epstein-Barr Virus (EBV)","Adenovirus (ADV)","Cytomegalovirus (CMV)","T-Cells","Donor","BK virus (BKV)","2025-12-10",{"date":119,"type":120},"2025-12-16","ACTUAL",{"date":122,"type":120},"2015-09-02",{"date":124,"type":101},"2027-12",{"name":5,"class":6},4]