[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"infusion-reactions\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:infusion-reactions":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,49],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":43,"leadSponsor":45,"locationsCount":48},"100639776","retrospective-kinetic-safety-evaluation-of-an-intravenous-micellar-excipient-platform-100639776",false,"NCT07609069","Retrospective Kinetic Safety Evaluation of an Intravenous Micellar Excipient Platform","Retrospective, Multi-Center Observational Study Evaluating the Kinetic Safety and Tolerability of an Intravenous Micellar Excipient Platform in Clinical Practice","Inclusion Criteria:\n\n* Participant must have received at least one intravenous (IV) investigational exposure of the PICO IV 850-picometer micellar platform (evaluating either a legacy heterogeneous payload or the PIV-850 synthetic-equivalent dual-NCE matrix) between June 1, 2025, and April 15, 2026.\n* The investigational product administered must have been drawn exclusively from a Single-Use Sterile Vial.\n* The participant record must have been identified via a 100% consecutive sampling algorithm (15 to 25 patients per site) at the clinical site to eliminate selection bias.\n* Electronic Medical Record (EMR) or clinic infusion logs must contain complete data regarding dosing, administration route (IV Push vs. IV Drip), and post-infusion safety observations.\n\nExclusion Criteria:\n\n* Participants whose exposures were drawn from legacy multi-use vials.\n* Participants with exposures occurring outside the specific date window of June 1, 2025 - April 15, 2026.\n* Participants with incomplete clinical records where Infusion-Emergent Adverse Events (IEAEs) or safety outcomes were not documented.\n* Participants whose records were not identified chronologically backward from April 15, 2026.","ALL","18 Years",{"count":19,"type":20},625,"ESTIMATED","OBSERVATIONAL","Protocol PICO-RWE-001: The goal of this observational study is to evaluate the kinetic safety and tolerability of an investigational intravenous micellar delivery platform. Researchers will abstract medical records of individuals who previously received this infusion in a clinical setting. The main questions the study aims to answer are: What adverse events (AEs) did participants experience during or after the infusion? Did participants discontinue their infusion regimen early due to adverse events? Researchers will abstract charts from clinical exposures occurring between June 1, 2025, and April 15, 2026. Participants do not undergo any new interventions or clinic visits.",[24,25],"Drug Related Side Effects and Adverse Reactions","Infusion Reactions",[27,28,29,30,31,32,33,34,35],"Sub-nanometer delivery system","Micellar nanotechnology","Real-World Evidence (RWE)","505(b)(2) Regulatory Pathway","Antimicrobial Resistance (AMR)","Biofilm Disruption","Excipient Safety","Polysorbate 80","Immunomodulation","NOT_YET_RECRUITING","2026-05-26",{"date":39,"type":40},"2026-05-29","ACTUAL",{"date":42,"type":20},"2026-05-21",{"date":44,"type":20},"2026-07-30",{"name":46,"class":47},"PICO IV, Inc.","INDUSTRY",1,{"id":50,"slug":51,"hasResults":11,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":4,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":68,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":79},"100182938","phase-2-safety-study-of-unlicensed-ind-cord-blood-units-manufactured-by-the-national-cord-blood-program-for-unrelated-transplantation-100182938","NCT01656603","Safety Study of Unlicensed IND Cord Blood Units Manufactured by the National Cord Blood Program for Unrelated Transplantation","A Multicenter Safety Study of Unlicensed, Investigational Cryopreserved Cord Blood Units Manufactured by the National Cord Blood Program and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients","Inclusion Criteria:\n\n1. Diagnosis: Patients with disorders affecting the hematopoietic system that are inherited, acquired, or result from myeloablative treatment.\n2. Patients: Patients of any age and either gender\n3. Cord blood product manufactured by the NCBP (at least one, if the graft contains more than one units)\n\nExclusion Criteria:\n\n1. Patients who are receiving licensed cord blood products (only)\n2. Patients who are receiving unlicensed cord blood products from other banks (only)\n3. Patients who are transplanted at non-US transplant centers\n4. Patients who are receiving cord blood products that will be \"manipulated\" post-thaw (e.g., ex vivo expansion, incubation in vitro, etc.)",{"count":57,"type":20},9999,"INTERVENTIONAL",[60],"PHASE2","This study will evaluate the safety of infusion of the investigational cord blood units by carefully documenting all infusion-related problems.",[25],[64,65,66,67],"cord blood","transplantation","stem cells","adverse event","RECRUITING","2026-04-06",{"date":71,"type":40},"2026-04-13",{"date":73,"type":4},"2012-02",{"date":75,"type":20},"2030-12",{"name":77,"class":78},"New York Blood Center","OTHER",71]