[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100516972":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":37,"responsibleParty":53,"collaborators":31,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":31,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":31,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":31,"overallStatus":39,"whyStopped":31,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Hospital Israelita Albert Einstein","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Lymphocyte infusion","EXPERIMENTAL","Patients with CMV disease or reactivation will be included for receiving donor-CMV-specific cells",[13],"Combination Product: Lymphocyte infusion (ImmuneCellVir-I)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"COMBINATION_PRODUCT","Lymphocyte infusion (ImmuneCellVir-I)","Infusion of donor CMV specific cells into patients eligible to the trial",[9],[21],"CMV-specific cells infusion",[23],{"name":24,"affiliation":5,"role":25},"Nelson Hamerschlak, MD, PhD","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Nelson C Hamerschlak, MD, PhD","CONTACT","+5511999614340",null,"hamer@einstein.br",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},"Luciana C Marti, PhD","+5511983716733","luciana.marti@einstein.br",[38],{"facility":5,"status":39,"city":40,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","São Paulo","05653000","Brazil","BR",{"type":45,"coordinates":46},"Point",[47,48],-46.63611,-23.5475,{"lat":48,"lon":47},[51,52],{"name":24,"role":29,"phone":30,"phoneExt":31,"email":32},{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},{"type":54,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100516972","phase-1-expansion-of-virus-specific-lymphocytes-for-cell-therapy-100516972",false,"NCT06011486","Expansion of Virus-Specific Lymphocytes for Cell Therapy","Expansion of Virus-Specific Lymphocytes for Cell Therapy in Immunosuppressed Patients Who Underwent Bone Marrow Transplantation.","Inclusion Criteria:\n\n* Be able to provide signed informed consent.\n* Must be between 18 and 75 years old at the time of signing the consent form\n* Having undergone allogeneic hematopoietic stem cell transplantation (related, unrelated, haploidentical or cord blood transplant)\n* Negative pregnancy test for women of childbearing age (non-fertile age defined as post-menopausal over one year, or surgically sterilized); Acceptance of the use of contraceptive methods by sexually active men and women of childbearing age;\n* Present with clinically significant CMV infection and one of the following conditions:\n* Refractory CMV infection, defined as over a 1log increase in blood or plasma CMV copies number after 2 weeks of treatment with appropriate anti-CMV medication (treatment with ganciclovir, valganciclovir, or foscarnet)\n* Probable refractory CMV infection, defined as persistence of CMV DNA in blood or plasma at the same level or under 1 log increase after 2 weeks of treatment with appropriate anti-CMV medication (treatment with ganciclovir, valganciclovir, or foscarnet)\n* Presence of resistant CMV, defined by the presence of a known genetic mutation that reduces susceptibility to one or more antiviral medications\n* Refractory CMV disease, defined as worsening of signs and symptoms and\u002For progression to CMV disease after 2 weeks of appropriate antiviral therapy\n* Restrictions or complications related to conventional therapy, which make it impossible to carry out conventional drug treatment defined as cytopenias with neutrophils under 1000 per microliter, platelets under 100,000 per microliter related to the use of ganciclovir or valganciclovir and nephrotoxicity with an increase of 1.5 times in the baseline creatinine with the use of foscavir.\n\nExclusion Criteria:\n\n* Patients who do not meet the inclusion criteria\n* Patients who do not agree to participate in the study or sign the consent form\n* Patients reporting allergy to murine antibodies or iron-dextran\n* Patients with grade 3 or 4 graft versus host disease\u002Fgraft versus host disease in activity\u002Ftreatment\n* Pregnant or lactating patients\n* Patients with uncontrolled bacterial and\u002For fungal infections","ALL","18 Years","75 Years",{"count":66,"type":67},10,"ESTIMATED","INTERVENTIONAL",[70],"PHASE1","Infections and reactivation of human cytomegalovirus (CMV), adenovirus, Epstein-barr and polyoma virus infections are frequent causes of morbidity and mortality and are a source of serious complications in patients undergoing allogeneic bone marrow transplantation.\n\nIn this project we will prepare specific T lymphocytes from blood donor, select cells CMV-specific by interferon gamma capture and treat patients with CMV viral infections. These cells will be used as antiviral therapy in transplanted patients whom do not respond to conventional therapies or in patients whose conventional therapy may be toxic in the context of transplantation. In this context, CMV reactivation can lead to serious complications in patients, such as irreversible neurological changes, pulmonary, gastrointestinal and ophthalmologic complications, among others, in addition to prolonged hospitalizations, leading to significant morbidity and mortality , both in the health sector public as private.\n\nThis project may represent an important therapeutic modality using cell of the shelf as a source of therapy for different patients and contributing to reduced morbidity \u002F mortality after transplantation, as well as a reduction in the hospitalization period.",[73,74],"CMV Viremia","CMV","2024-10-22",{"date":77,"type":78},"2024-10-24","ACTUAL",{"date":80,"type":78},"2024-06-10",{"date":82,"type":67},"2026-06-10",{"name":5,"class":6},1]