[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100249954":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":33,"responsibleParty":90,"collaborators":19,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":19,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":19,"enrollmentInfo":101,"targetDuration":19,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":112,"overallStatus":36,"whyStopped":19,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"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",[34,55,65,75],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Akron Children's Hospital","RECRUITING","Akron","Ohio","44308","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-81.51901,41.08144,{"lat":46,"lon":45},[49,53],{"name":50,"role":27,"phone":51,"phoneExt":19,"email":52},"Courtney Culbertson, CNP","330-543-3338","cculbertson@akronchildrens.org",{"name":54,"role":23,"phone":19,"phoneExt":19,"email":19},"Megan Sampson, MD",{"facility":56,"status":57,"city":58,"state":38,"zip":59,"country":40,"countryCode":41,"cosmosGeoPoint":60,"geoPoint":64,"contacts":19},"University of Cincinnati Medical Center","COMPLETED","Cincinnati","45219",{"type":43,"coordinates":61},[62,63],-84.51439,39.12711,{"lat":63,"lon":62},{"facility":66,"status":36,"city":58,"state":38,"zip":67,"country":40,"countryCode":41,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"Cincinnati Children's Hospital Medical Center","45229",{"type":43,"coordinates":69},[62,63],{"lat":63,"lon":62},[72,74],{"name":26,"role":27,"phone":73,"phoneExt":19,"email":29},"513-803-1102",{"name":31,"role":23,"phone":19,"phoneExt":19,"email":19},{"facility":76,"status":36,"city":77,"state":38,"zip":78,"country":40,"countryCode":41,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"The Ohio State University Wexner Medical Center - James Cancer Hospital","Columbus","43210",{"type":43,"coordinates":80},[81,82],-82.99879,39.96118,{"lat":82,"lon":81},[85,88],{"name":86,"role":27,"phone":19,"phoneExt":19,"email":87},"Nicole Szuminski, MS, RN, CCRC","nicole.szuminski@osumc.edu",{"name":89,"role":23,"phone":19,"phoneExt":19,"email":19},"Polina Shindiapina, MD, PhD",{"type":91,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100249954","phase-2-third-party-viral-specific-t-cells-vsts-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":102,"type":103},750,"ESTIMATED","INTERVENTIONAL",[106],"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.",[109,110,111],"Viral Infection","Viral Reactivation","Infection in an Immunocompromised Host",[113,114,115,116,117,118],"Epstein-Barr Virus (EBV)","Adenovirus (ADV)","Cytomegalovirus (CMV)","T-Cells","Donor","BK virus (BKV)","2025-12-10",{"date":121,"type":122},"2025-12-16","ACTUAL",{"date":124,"type":122},"2015-09-02",{"date":126,"type":103},"2027-12",{"name":5,"class":6},4]