[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100597402":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":39,"locations":48,"responsibleParty":169,"collaborators":171,"id":177,"slug":178,"hasResults":179,"nctId":180,"briefTitle":181,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":179,"sex":185,"minAge":186,"maxAge":187,"enrollmentInfo":188,"targetDuration":34,"studyType":191,"phases":192,"briefSummary":194,"conditions":195,"keywords":198,"overallStatus":205,"whyStopped":34,"lastUpdateSubmitDate":206,"lastUpdatePostDateStruct":207,"startDateStruct":210,"completionDateStruct":212,"leadSponsor":214,"locationsCount":215},{"fullName":5,"class":6},"Ottawa Hospital Research Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group will receive multiple IV doses of UC-MSCs","EXPERIMENTAL","* Dose: each dose consists of 10 million cells\u002Fkilograms of bodyweight.\n* Administration protocol: weekly (7 days ± 1 day) IV dose of UC-MSCs for 3 weeks (Total of 3 doses)\n* Route of administration: IV infusion on peripheral intravenous catheter. The UC-MSC solution will be infused using a syringe pump over 15 minutes, and after the UCMSC infusion, an additional volume of normal saline will be infused over 15 minutes.",[13],"Biological: Human Allogenic Umbilical Cord Mesenchymal Stromal Cells",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","SHAM_COMPARATOR","Participants allocated in the control group will receive a sham procedure weekly for 3 weeks. A syringe of normal saline brought to bedside, but it will not be administered. The physician and bedside nurse will perform the sham procedure behind a screen (they will mimic IV catheter insertion and cell product injection)",[19],"Other: Sham procedure control",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BIOLOGICAL","Human Allogenic Umbilical Cord Mesenchymal Stromal Cells","IV administration of uc-MSC every 7 days ± 1 day for 3 weeks. Randomized double blinded",[9],[27,28,29],"UC-MSC","Umbilical Cord Mesenchymal Stromal Cells","Mesenchymal Stromal Cells",{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Sham procedure control","Sham procedure (mimic IV catheter insertion adn cell product infusion behing a screen). Repeated weekly for 3 weeks",[15],null,[36],{"name":37,"affiliation":5,"role":38},"Bernard Thébaud, MD, PhD","PRINCIPAL_INVESTIGATOR",[40,45],{"name":37,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","613-737-8899","73905","bthebaud@toh.ca",{"name":46,"role":41,"phone":34,"phoneExt":34,"email":47},"Chantal Horth","chorth@cheo.on.ca",[49,68,84,93,111,124,141,153],{"facility":50,"status":34,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Royal Alexandra Hospital\u002FStollery Children's Hospital","Edmonton","Alberta","T5H 3V9","Canada","CA",{"type":57,"coordinates":58},"Point",[59,60],-113.46871,53.55014,{"lat":60,"lon":59},[63,67],{"name":64,"role":41,"phone":65,"phoneExt":34,"email":66},"Georg Schmölzer, MD, PhD","780-735-4660","georg.schmoelzer@me.com",{"name":64,"role":38,"phone":34,"phoneExt":34,"email":34},{"facility":69,"status":34,"city":70,"state":71,"zip":72,"country":54,"countryCode":55,"cosmosGeoPoint":73,"geoPoint":77,"contacts":78},"McMaster Children's Hospital","Hamilton","Ontario","L8Z 3Z5",{"type":57,"coordinates":74},[75,76],-79.84963,43.25011,{"lat":76,"lon":75},[79,83],{"name":80,"role":41,"phone":81,"phoneExt":34,"email":82},"Amit Mukerji","905-521-2100","mukerji@mcmaster.ca",{"name":80,"role":38,"phone":34,"phoneExt":34,"email":34},{"facility":85,"status":34,"city":86,"state":71,"zip":87,"country":54,"countryCode":55,"cosmosGeoPoint":88,"geoPoint":92,"contacts":34},"The Ottawa Hospital","Ottawa","K1H 8L6",{"type":57,"coordinates":89},[90,91],-75.69812,45.41117,{"lat":91,"lon":90},{"facility":94,"status":34,"city":95,"state":71,"zip":96,"country":54,"countryCode":55,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"Sunnybrook Health Sciences Ctr","Toronto","M4Y 3M5",{"type":57,"coordinates":98},[99,100],-79.39864,43.70643,{"lat":100,"lon":99},[103,107,108],{"name":104,"role":41,"phone":105,"phoneExt":34,"email":106},"Maher Shahroor, MD, RCPSC","416-480-6100","maher.shahroor@sunnybrook.ca",{"name":104,"role":38,"phone":34,"phoneExt":34,"email":34},{"name":109,"role":110,"phone":34,"phoneExt":34,"email":34},"Elizabeth Asztalos, MD, MSc, FRCPC","SUB_INVESTIGATOR",{"facility":112,"status":34,"city":95,"state":71,"zip":113,"country":54,"countryCode":55,"cosmosGeoPoint":114,"geoPoint":116,"contacts":117},"Mount Sinai Hospital","M5G 1X5",{"type":57,"coordinates":115},[99,100],{"lat":100,"lon":99},[118,122],{"name":119,"role":41,"phone":120,"phoneExt":34,"email":121},"Prakesh Shah","416-586-4761","prakeshkumar.shah@sinaihealth.ca",{"name":123,"role":38,"phone":34,"phoneExt":34,"email":34},"Prakesh Shah, MD",{"facility":125,"status":34,"city":126,"state":127,"zip":128,"country":54,"countryCode":55,"cosmosGeoPoint":129,"geoPoint":133,"contacts":134},"CHU Sainte-Justine","Montreal","Quebec","H3T 1C5",{"type":57,"coordinates":130},[131,132],-73.58781,45.50884,{"lat":132,"lon":131},[135,140],{"name":136,"role":41,"phone":137,"phoneExt":138,"email":139},"Anne-Monique Nuyt","514 345-4931","4673","anne.monique.nuyt@umontreal.ca",{"name":136,"role":38,"phone":34,"phoneExt":34,"email":34},{"facility":142,"status":34,"city":126,"state":127,"zip":143,"country":54,"countryCode":55,"cosmosGeoPoint":144,"geoPoint":146,"contacts":147},"McGill Montreal Children's Hospital","H4A 3J1",{"type":57,"coordinates":145},[131,132],{"lat":132,"lon":131},[148,152],{"name":149,"role":41,"phone":150,"phoneExt":34,"email":151},"Marc Beltempo, MD, M.Sc., FRCPC","(514) 412-4400","marc.beltempo@mcgill.ca",{"name":149,"role":38,"phone":34,"phoneExt":34,"email":34},{"facility":154,"status":34,"city":155,"state":127,"zip":156,"country":54,"countryCode":55,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Université Laval","Québec","G1V 0B4",{"type":57,"coordinates":158},[159,160],-71.21454,46.81228,{"lat":160,"lon":159},[163,167],{"name":164,"role":41,"phone":165,"phoneExt":34,"email":166},"Mireille Guillot, MD","418-656-2131","mireille.guillot.1@ulaval.ca",{"name":168,"role":38,"phone":34,"phoneExt":34,"email":34},"Mireille Guillot",{"type":170,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[172,175],{"name":173,"class":174},"Canadian Institutes of Health Research (CIHR)","OTHER_GOV",{"name":176,"class":6},"Stem Cell Network","100597402","phase-2-mesenchymal-stromal-cell-therapy-to-prevent-bronchopulmonary-dysplasia-in-extreme-preterm-infants-100597402",false,"NCT07058025","Mesenchymal Stromal Cell Therapy to Prevent Bronchopulmonary Dysplasia in Extreme Preterm Infants","Mesenchymal Stromal Cells in Extreme Preterm Infants at Risk of Developing Bronchopulmonary Dysplasia - A Phase 2 Multi-Centre Double Blind Randomized Controlled Trial","HULC-2","Inclusion Criteria:\n\n* Gestational age (GA) less than 28+0 weeks\n* Post-natal age between 4 and 14 days of life\n* Invasive ventilation with oxygen requirement:\n\n  * On mechanical ventilation: intubated patient with any of the following ventilation modes: conventional, HFO or Jet ventilation:\n  * With requirement of FiO2: FiO2 \\>= 30% and for at least 12 hours over 24 hours (i.e. flowsheets, FiO2 histogram)\n\nExclusion Criteria:\n\n1. Congenital anomaly:\n\n   * Genetic and chromosomal syndromes (e.g., Trisomy 13, Trisomy 18, Trisomy 21): either patient with high suspicion (antenatal findings, clinical features) or documented syndrome by genetic testing.\n   * Major congenital anomalies including cardiac (i.e., congenital heart defects, NB. PDA is not considered an exclusion criterion), neurological (e.g., holoprosencephaly, anencephaly), gastrointestinal (e.g., gastroschisis, omphalocele), pulmonary (e.g., congenital diaphragmatic hernia) anomalies.\n   * Inborn errors of metabolism.\n2. Hemodynamic instability (shock):\n\n   * Hemodynamic instability with impaired end-organ perfusion (metabolic acidosis with increased lactate and\u002For decreased urine output).\n   * Requirements for fluid bolus, inotrope or vasopressor medication\n3. Severe sepsis:\n\n   * Signs of hemodynamic instability and requiring at least one fluid bolus.\n   * And a positive blood or cerebrospinal fluid culture.\n4. Pneumothorax: Pneumothorax with a chest tube in place\n5. Severe pulmonary hemorrhage:\n\n   * Active pulmonary hemorrhage (i.e., frank blood coming from the endotracheal tube.\n   * And at least one of the following criteria: a)hemodynamic instability. b) blood product transfusion (packed red blood cells, platelets, fresh frozen plasma)\n6. Extubation: If Extubation planned within the next 24 hours (post first uc-MSC administration\u002Fsham procedure).\n7. Patient is not expected to survive:\n\n   * Redirection of care.\n   * Patient is moribund","ALL","4 Days","14 Days",{"count":189,"type":190},168,"ESTIMATED","INTERVENTIONAL",[193],"PHASE2","This clinical trial aims to evaluate the safety and efficacy of mesenchymal stromal cell (MSC) therapy in extreme preterm infants to prevent bronchopulmonary dysplasia, the main respiratory complication of preterm birth.\n\nStudy participants will receive either multiple intravenous doses (total of 3 doses) of MSC derived from human donor umbilical cord tissue (intervention group) or no uc-MSC injection (control group) to confirm the safety of IV MSC in extreme preterm infants and evaluate the potential benefit of MSC therapy on their respiratory health as well as on other complications related to preterm birth.",[196,197],"Bronchopulmonary Dysplasia (BPD)","ELGAN (22-28SA)",[199,200,201,202,203,204],"Phase II clinical trial","Mesenchymal stromal cell","Cell therapy","Preterm infant","Bronchopulmonary Dysplasia","Extremely low gestational age neonates","NOT_YET_RECRUITING","2025-07-08",{"date":208,"type":209},"2025-07-10","ACTUAL",{"date":211,"type":190},"2025-10-01",{"date":213,"type":190},"2038-09-30",{"name":5,"class":6},8]