[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100167322":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":20,"locations":25,"responsibleParty":46,"collaborators":20,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":20,"eligibilityCriteria":53,"healthyVolunteers":50,"sex":54,"minAge":20,"maxAge":20,"enrollmentInfo":55,"targetDuration":20,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":65,"overallStatus":27,"whyStopped":20,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":76},{"fullName":5,"class":6},"Masonic Cancer Center, University of Minnesota","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Unlicensed Umbilical Cord Blood Infusion","EXPERIMENTAL","All patients will be registered in OnCore under this protocol as well as the specific treatment protocol.\n\n* Pre-infusion treatment using intravenous hydration, acetaminophen and diphenhydramine hydrochloride\n* Unlicensed Umbilical Cord Blood Infusion according to institutional guidelines.\n\n  * Infusion of minimally manipulated unlicensed UCB units:\n  * vital signs Monitoring during and after UCB infusion:\n  * Management of infusion reactions\n* Post-transplant care and follow-up: will be done according to the disease specific treatment protocol and institutional guidelines.",[13],"Biological: Umbilical Cord Blood (UCB)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Umbilical Cord Blood (UCB)","Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Alex Hoover, MD, MSc","PRINCIPAL_INVESTIGATOR",[26],{"facility":5,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"RECRUITING","Minneapolis","Minnesota","55455","United States","US",{"type":34,"coordinates":35},"Point",[36,37],-93.26384,44.97997,{"lat":37,"lon":36},[40,45],{"name":41,"role":42,"phone":43,"phoneExt":20,"email":44},"Claudio Brunstein, MD","CONTACT","612-625-3918","bruns072@umn.edu",{"name":41,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":47,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100167322","infusion-of-cell-populations-from-unlicensed-umbilical-cord-blood-units-100167322",false,"NCT01451502","Infusion of Cell Populations From Unlicensed Umbilical Cord Blood Units","Inclusion Criteria:\n\nTo be eligible for an unlicensed umbilical cord blood (UCB) unit, the subject must meet each of the eligibility criteria listed below:\n\n* Subjects with any diagnosis for which there is an institutional review board (IRB) approved treatment protocol that requires UCB as a source of hematopoietic stem cells for lympho-hematopoietic reconstitution after myeloablative or non myeloablative conditioning.\n* Subject (or parent\u002Fguardian) must provide written informed consent for the use of unlicensed UCB units with co-enrollment onto a University of Minnesota IRB-approved clinical trial that details the disease specific treatment plan that prescribes the use of UCB as source of cells\n* Subject has an unlicensed UCB unit that meets required cell dose and HLA matching criteria (as defined in the primary treatment protocol) that is considered negative for tested blood-borne pathogens and also lack an 'equivalent', licensed UCB unit from a University of Minnesota approved Cord Blood Bank\n\nExclusion Criteria:\n\n* Exclusion criteria are specified in the treatment protocol according to indication.","ALL",{"count":56,"type":57},250,"ESTIMATED","INTERVENTIONAL",[60],"NA","For the next 5-10 years or possibly longer, a high proportion of the Cord Blood Banks (CBB) inventory worldwide will be composed of unlicensed umbilical cord blood (UCB) units. While Food and Drug Administration (FDA)-licensed units will be prioritized, it will always be possible that an unlicensed unit will have known attributes, making it a better source of cells for the given indication. Because of the wide variety of current and potential indications as a source of cells for hematopoietic reconstitution or other form of cellular therapy, it is critical that the investigators have access to unlicensed UCB units.",[63,64],"Lymphatic Diseases","Hematopoietic Malignancy",[66],"umbilical cord blood","2026-05-07",{"date":69,"type":70},"2026-05-08","ACTUAL",{"date":72,"type":70},"2011-10-20",{"date":74,"type":57},"2027-02",{"name":5,"class":6},1]