Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-29 @ 10:29 PM
Study NCT ID:
NCT04003857
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-07
First Post:
2019-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2019-06-19', 'studyFirstSubmitQcDate': '2019-06-28', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Respiratory outcome: Number of hospitalizations', 'timeFrame': '6 months corrected age', 'description': 'Total number of hospitalizations and the number of hospital stay due to respiratory infection'}, {'measure': 'Respiratory outcome: Number of hospitalizations', 'timeFrame': '12 months corrected age', 'description': 'Total number of hospitalizations and the number of hospital stay due to respiratory infection'}, {'measure': 'Respiratory outcome: Number of hospitalizations', 'timeFrame': '18 months corrected age', 'description': 'Total number of hospitalizations and the number of hospital stay due to respiratory infection is recorded and compared with control group'}, {'measure': 'Respiratory outcome: Number of hospitalizations', 'timeFrame': '24 months corrected age', 'description': 'Total number of hospitalizations and the number of hospital stay due to respiratory infection'}, {'measure': 'Respiratory outcome: Number of hospitalizations', 'timeFrame': '36 months after birth', 'description': 'Total number of hospitalizations and the number of hospital stay due to respiratory infection'}, {'measure': 'Respiratory outcome: Number of hospitalizations', 'timeFrame': '39 months after birth', 'description': 'Total number of hospitalizations and the number of hospital stay due to respiratory infection'}, {'measure': 'Respiratory outcome: Number of hospitalizations', 'timeFrame': '42 months after birth', 'description': 'Total number of hospitalizations and the number of hospital stay due to respiratory infection'}, {'measure': 'Respiratory outcome: Number of hospitalizations', 'timeFrame': '45 months after birth', 'description': 'Total number of hospitalizations and the number of hospital stay due to respiratory infection'}, {'measure': 'Respiratory outcome: Number of hospitalizations', 'timeFrame': '48 months after birth', 'description': 'Total number of hospitalizations and the number of hospital stay due to respiratory infection'}, {'measure': 'Respiratory outcome: Number of hospitalizations', 'timeFrame': '51 months after birth', 'description': 'Total number of hospitalizations and the number of hospital stay due to respiratory infection'}, {'measure': 'Respiratory outcome: Number of hospitalizations', 'timeFrame': '54 months after birth', 'description': 'Total number of hospitalizations and the number of hospital stay due to respiratory infection'}, {'measure': 'Respiratory outcome: Number of hospitalizations', 'timeFrame': '57 months after birth', 'description': 'Total number of hospitalizations and the number of hospital stay due to respiratory infection'}, {'measure': 'Respiratory outcome: Number of hospitalizations', 'timeFrame': '60 months after birth', 'description': 'Total number of hospitalizations and the number of hospital stay due to respiratory infection'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth', 'description': 'check whether patient is alive or dead at evaluation time point'}, {'measure': 'Growth measured by Z-score', 'timeFrame': '6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth', 'description': 'Growth measured by Z-score'}, {'measure': 'Neurological developmental status: Korean Developmental Screening Test for infants and children(K-DST)', 'timeFrame': '6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth', 'description': 'Neurological developmental status on Korean Developmental Screening Test for infants and children(K-DST)'}, {'measure': 'Deafness or Blindness', 'timeFrame': '24 months corrected age', 'description': 'Deafness: audiometry /Blindness: examination of extraocular muscle, fundus photography, optical biometry'}, {'measure': 'Bayley Scales of Infant and Toddler Development (Third Edition)', 'timeFrame': '18~24months corrected age, 36~42months after birth', 'description': 'Scale: cognitive, motor, language, social-emotional, adaptive behavior'}, {'measure': 'Gross Motor Function Classification System for Cerebral Palsy', 'timeFrame': '24 months corrected age', 'description': 'Gross Motor Function Classification System for Cerebral Palsy'}, {'measure': 'Number of adverse events', 'timeFrame': '6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth', 'description': 'Number of adverse events'}, {'measure': 'Number of admissions to Emergency Room (ER)', 'timeFrame': '6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth', 'description': 'Total number of admissions to Emergency Room (ER) and number of admission to Emergency Room (ER) due to respiratory infection at each evaluation time point'}, {'measure': 'Medical treatment records', 'timeFrame': '6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth', 'description': 'whether or not, the patient is receiving medical treatment(use of oxygen, steroid, or bronchodilator, diuretics, Sildenafil) and if receiving treatment, the duration of the treatment at each evaluation time point'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Human Umbilical Cord Blood Derived Mesenchymal Stem Cells', 'Bronchopulmonary dysplasia', 'Premature infants'], 'conditions': ['Bronchopulmonary Dysplasia', 'BPD']}, 'descriptionModule': {'briefSummary': 'This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the Phase II trial (NCT03392467) will be followed-up until 60 months of corrected age', 'detailedDescription': 'Subjects who completed the initial stage of the Phase II clinical trial will be followed-up at 7 additional visits: 6, 12,18, 24 months corrected age, 36, 48, and 60 months after birth.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '60 Months', 'minimumAge': '6 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject who enrolled in phase 2 clinical trial of PNEUMOSTEM® to evaluate efficacy and safety, and were administered with investigational product\n* Subject with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial\n\nExclusion Criteria:\n\n* Subject whose parent or legal representative does not agree to participate in the study\n* Subject who is considered inappropriate to participate in the study by the investigator'}, 'identificationModule': {'nctId': 'NCT04003857', 'briefTitle': 'Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medipost Co Ltd.'}, 'officialTitle': 'Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial', 'orgStudyIdInfo': {'id': 'MP-CR-012-F/U'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PNEUMOSTEM®', 'description': 'A single intratracheal administration of Pneumostem® (10.0 x 10\\^6 cells/kg)', 'interventionNames': ['Biological: PNEUMOSTEM®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'normal saline', 'description': 'A single intratracheal administration of normal saline', 'interventionNames': ['Biological: normal saline']}], 'interventions': [{'name': 'PNEUMOSTEM®', 'type': 'BIOLOGICAL', 'otherNames': ['Human umbilical cord blood-derived mesenchymal stem cells'], 'description': 'A single intratracheal administration of PNEUMOSTEM® (1.0 x 10\\^7 cells/kg)', 'armGroupLabels': ['PNEUMOSTEM®']}, {'name': 'normal saline', 'type': 'BIOLOGICAL', 'description': 'A single intratracheal administration of normal saline', 'armGroupLabels': ['normal saline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'Samsung Medical Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Wonsoon Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatrics, Samsung Medical Center'}, {'name': 'Ai-Rhan Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neonatology, Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipost Co Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}