[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100159081":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":11,"locations":34,"responsibleParty":48,"collaborators":52,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":69,"acronym":11,"eligibilityCriteria":70,"healthyVolunteers":67,"sex":71,"minAge":72,"maxAge":73,"enrollmentInfo":74,"targetDuration":11,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":87,"whyStopped":88,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Memorial Hermann Health System","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Biologic; Autologous Cell Injection","EXPERIMENTAL",null,[13],"Biological: Autologous Human Umbilical Cord Blood",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BIOLOGICAL","Autologous Human Umbilical Cord Blood","6 million cells\u002Fkg will be administered intravenously at one treatment time point.",[9],[21,22],"Autologous Human Umbilical Cord Blood Mononuclear Fraction Cells","Patient's Own Stem Cells",[24,28,31],{"name":25,"affiliation":26,"role":27},"James E. Baumgartner, MD","MHHS, Houston,TX & FL Hospital for Children, Orlando, FL","PRINCIPAL_INVESTIGATOR",{"name":29,"affiliation":30,"role":27},"Linda S. Baumgartner, CCC-SLP, LSLS CERT.AVT","Speech Therapists for Children",{"name":32,"affiliation":33,"role":27},"Samir Fakhri, MD","The University of Texas Health Science Center, Houston",[35],{"facility":36,"status":11,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":11},"Children's Memorial Hermann Hospital","Houston","Texas","77030","United States","US",{"type":43,"coordinates":44},"Point",[45,46],-95.36327,29.76328,{"lat":46,"lon":45},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Aryn Knight","AVP Research",[53,56,57,59,61,63],{"name":54,"class":55},"Cord Blood Registry, Inc.","INDUSTRY",{"name":33,"class":6},{"name":58,"class":6},"M.D. Anderson Cancer Center",{"name":60,"class":6},"Baylor College of Medicine",{"name":62,"class":6},"The Methodist Hospital Research Institute",{"name":64,"class":6},"Florida Hospital for Children","100159081","phase-1-safety-of-autologous-human-umbilical-cord-blood-mononuclear-fraction-to-treat-acquired-hearing-loss-in-children-100159081",false,"NCT01343394","Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children","Inclusion Criteria:\n\n1. Evidence of a moderate to profound sensorineural hearing loss.\n2. Normally shaped cochlea, as determined by MRI.\n3. The loss must be considered acquired, NOT syndromic.\n4. The patient must be fitted for hearing aids of the detection of the loss.\n5. Enrollment in a parent\u002Fchild intervention program.\n6. Between 6 weeks and 18 months of age at the time of cord blood infusion.\n7. Ability of child and caregiver to travel to Houston for treatment and all follow-up appointments. (Patient's family is responsible for the cost of travel to and lodging in Houston).\n\nExclusion Criteria:\n\n1. Inability to obtain pertinent medical records.\n2. Known history or\n\n   * Recently treated ear or other infection.\n   * Renal disease.\n   * Hepatic disease.\n   * Malignancy.\n   * HIV.\n   * Immunosuppression (WBC \\\u003C 3,000).\n   * Evidence of an extensive stroke (\\> 100ml).\n   * Pneumonia, or chronic lung disease.\n3. hUCB sample contamination.\n4. Participation in a concurrent intervention study.\n5. Desire for organ donation in the event of death.\n6. Unwillingness or inability to stay 4 days following hUCB infusion, and to return for the one month, six month and one year follow-up visits.\n7. Presence of a cochlear implant device.\n8. Evidence of a syndrome.\n9. Positive test for genetic hearing loss.\n10. Evidence of conductive hearing loss.\n11. Documented evidence of recurrent middle ear infections (\\> 5\u002Fyear).\n12. Otitis media at the time of examination.\n13. Mild sensorineural hearing loss.\n14. Over 18 months at the time of infusion.","ALL","6 Weeks","18 Months",{"count":75,"type":76},0,"ACTUAL","INTERVENTIONAL",[79],"PHASE1","The objectives of this study are:\n\n1. To see if autologous human umbilical cord blood treatment is safe for children with acquired hearing loss, and\n2. To determine if late functional outcome is improved following autologous human umbilical cord blood treatment for children with acquired hearing loss.",[82],"Hearing Loss",[84,85,82,86],"Autologous","Stem Cells","Children","WITHDRAWN","UT-IRB insists on protocol design change -Not rel to any pt. safety\u002Fnon-compliance-Recruiting halted at UT\u002FMHHS but may resume at FLHosp for Children-OrlandoFL","2024-03-18",{"date":91,"type":76},"2024-03-20",{"date":93,"type":11},"2011-04",{"date":95,"type":96},"2016-04","ESTIMATED",{"name":50,"class":6},1]