Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-30 @ 10:26 AM
Study NCT ID:
NCT01343394
Status:
WITHDRAWN
Last Update Posted:
2024-03-20
First Post:
2011-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D034381', 'term': 'Hearing Loss'}], 'ancestors': [{'id': 'D006311', 'term': 'Hearing Disorders'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'UT-IRB insists on protocol design change -Not rel to any pt. safety/non-compliance-Recruiting halted at UT/MHHS but may resume at FLHosp for Children-OrlandoFL', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2016-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2011-04-25', 'studyFirstSubmitQcDate': '2011-04-27', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-04-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Physiologic Outcome', 'timeFrame': 'One year', 'description': 'Age appropriate physiologic outcome measures will be recorded pre-treatment, and one year following hUCB treatment'}], 'secondaryOutcomes': [{'measure': 'Functional Outcome', 'timeFrame': 'one year', 'description': 'Age appropriate Speech-Language assessments will be performed pre-treatment and one year post-treatment.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Autologous', 'Stem Cells', 'Hearing Loss', 'Children'], 'conditions': ['Hearing Loss']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': 'Acquired sensorineural hearing loss is characterized by a loss of functioning hair cells in the Organ of Corti, with greater hair cell loss correlating with more severe hearing impairment. Children with sensorineural hearing loss experience difficulty developing normal language which usually leads to poor academic and social development. Currently, there are no reparative therapeutic options available, and treatments are designed to augment the diminished function of the injured Organ of Corti.\n\nPre-clinical data suggest progenitor cell infusions may enhance intrinsic repair mechanisms in the Organ of Corti which may restore hair cells. This treatment could ultimately lead to hearing improvement. Human umbilical cord blood (hUCB) is an available, autologous, stored progenitor cell population available for potential therapeutic use. The primary objective of this study is to determine the safety of autologous hUCB infusion in children with acquired hearing loss. The secondary objective is to determine if functional, physiologic and anatomic outcomes are improved following hUCB treatment in this patient population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '18 Months', 'minimumAge': '6 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': "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/child 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 \\< 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/year).\n12. Otitis media at the time of examination.\n13. Mild sensorineural hearing loss.\n14. Over 18 months at the time of infusion."}, 'identificationModule': {'nctId': 'NCT01343394', 'briefTitle': 'Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Hermann Health System'}, 'officialTitle': 'Safety of Autologous Human Umbilical Cord Blood Mononuclear Fraction to Treat Acquired Hearing Loss in Children', 'orgStudyIdInfo': {'id': 'JB IND14312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biologic; Autologous Cell Injection', 'interventionNames': ['Biological: Autologous Human Umbilical Cord Blood']}], 'interventions': [{'name': 'Autologous Human Umbilical Cord Blood', 'type': 'BIOLOGICAL', 'otherNames': ['Autologous Human Umbilical Cord Blood Mononuclear Fraction Cells', "Patient's Own Stem Cells"], 'description': '6 million cells/kg will be administered intravenously at one treatment time point.', 'armGroupLabels': ['Biologic; Autologous Cell Injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Children's Memorial Hermann Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'James E. Baumgartner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MHHS, Houston,TX & FL Hospital for Children, Orlando, FL'}, {'name': 'Linda S. Baumgartner, CCC-SLP, LSLS CERT.AVT', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Speech Therapists for Children'}, {'name': 'Samir Fakhri, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aryn Knight', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cord Blood Registry, Inc.', 'class': 'INDUSTRY'}, {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, {'name': 'Baylor College of Medicine', 'class': 'OTHER'}, {'name': 'The Methodist Hospital Research Institute', 'class': 'OTHER'}, {'name': 'Florida Hospital for Children', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'AVP Research', 'investigatorFullName': 'Aryn Knight', 'investigatorAffiliation': 'Memorial Hermann Health System'}}}}