Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-27 @ 4:29 PM
Study NCT ID:
NCT01828957
Status:
COMPLETED
Last Update Posted:
2019-09-06
First Post:
2013-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants
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': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 69}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-04', 'studyFirstSubmitDate': '2013-04-02', 'studyFirstSubmitQcDate': '2013-04-08', 'lastUpdatePostDateStruct': {'date': '2019-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of BPD (moderate to severe) or mortality at 36 weeks PMA', 'timeFrame': '36 weeks PMA', 'description': 'Incidence of BPD (moderate to severe) or mortality rate at 36 weeks PMA'}], 'secondaryOutcomes': [{'measure': 'Intubation duration', 'timeFrame': '36 weeks PMA'}, {'measure': 'Incidence of BPD', 'timeFrame': '28-days since birth'}, {'measure': 'Survival rate', 'timeFrame': '28-days since birth, 36 weeks PMA, and termination of the trial'}, {'measure': 'Duration of ventilator dependence', 'timeFrame': 'Week 24'}, {'measure': 'Duration of CPAP treatment', 'timeFrame': 'Week 24'}, {'measure': 'Postnatal steroid use (%) for the purpose of ventilator weaning', 'timeFrame': 'Week 24'}, {'measure': 'Cumulative duration of oxygen use', 'timeFrame': 'Week 24'}, {'measure': 'Incidence of Retinopathy of Prematurity (ROP) of Grade III or more', 'timeFrame': 'Week 24'}, {'measure': 'Retinopathy of Prematurity (ROP) that require treatment with avastin or laser', 'timeFrame': 'Week 24'}, {'measure': 'Growth velocity (Z-score)', 'timeFrame': 'Week 24'}, {'measure': 'Length of stay prior to the first discharge from the hospital', 'timeFrame': 'duration of the hospital stay, an expected average of approximately 3 months since birth'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Week 24'}, {'measure': 'Clinically significant laboratory findings', 'timeFrame': 'Week 24'}, {'measure': 'Incidence of pneumothorax that require intubation', 'timeFrame': 'Week 24'}, {'measure': 'Incidence of moderate to severe pulmonary hemorrhage', 'timeFrame': 'Week 24'}, {'measure': 'Incidence of intraventricular hemorrhage of grade 3 or more', 'timeFrame': 'Week 24'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Human Umbilical Cord Blood Derived Mesenchymal Stem Cells', 'Bronchopulmonary dysplasia', 'Premature infants'], 'conditions': ['Bronchopulmonary Dysplasia']}, 'referencesModule': {'references': [{'pmid': '33876883', 'type': 'DERIVED', 'citation': 'Ahn SY, Chang YS, Lee MH, Sung SI, Lee BS, Kim KS, Kim AR, Park WS. Stem cells for bronchopulmonary dysplasia in preterm infants: A randomized controlled phase II trial. Stem Cells Transl Med. 2021 Aug;10(8):1129-1137. doi: 10.1002/sctm.20-0330. Epub 2021 Apr 20.'}], 'seeAlsoLinks': [{'url': 'http://clinicaltrials.gov/ct2/show/NCT01297205?term=medipost&rank=2', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the efficacy and safety of a single intratracheal administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk premature infants by comparing Pneumostem-treated group with a control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '5 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 5 - 14 days since birth\n* Fetal gestational age: ≥23 weeks and \\<29 weeks\n* Birth weight: ≥500g and ≤1250g\n* Premature infant of equal to or less than 2 weeks of age who is receiving a ventilator therapy at a rate of \\> 12 breath/min and \\> 25% oxygen\n* Patient whose ventilator setting has not been changed and who has shown aggravation of the illness within the 24 hours prior to the study enrollment\n* Patient with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial\n\nExclusion Criteria:\n\n* Patient with concurrent cyanotic or acyanotic congenital heart diseases, except for patent ductus arteriosus\n* Patient with a concurrent severe lung malformation (i.e. Pulmonary hypoplasia, congenital diaphragmatic hernia, congenital cystic lung disease)\n* Patient with a concurrent severe lung malformation with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc)\n* Patient with a concurrent severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc)\n* Patient withCRP \\> 30 mg/dL; Severe sepsis or shock\n* Patient who is scheduled for or expected to undergo a surgical procedure 72 hours prior to/following the administration of the study drug\n* Patient who has been administered with a surfactant within the 24 hours prior to the administration of the study drug\n* Patient with severe intracranial hemorrhage ≥ grade 3 or 4\n* Patient with active pulmonary hemorrhage or active air leak syndrome at the time of screening\n* Patient with a history of participating in other clinical studies\n* Patient who is allergic to Gentamicin\n* Patient who is considered inappropriate to participate in the study by the investigator'}, 'identificationModule': {'nctId': 'NCT01828957', 'briefTitle': 'Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medipost Co Ltd.'}, 'officialTitle': 'Randomized, Double-blind, Multi-center, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Pneumostem® Versus a Control Group for Treatment of Bronchopulmonary Dysplasia in Premature Infants', 'orgStudyIdInfo': {'id': 'MP-CR-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pneumostem®', 'description': 'A single intratracheal administration of Pneumostem® (1.0 x 10\\^7 cells/kg)', 'interventionNames': ['Biological: Pneumostem®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'normal saline', 'description': 'A single intratracheal administration of normal saline', 'interventionNames': ['Other: Normal Saline']}], 'interventions': [{'name': 'Pneumostem®', 'type': 'BIOLOGICAL', 'otherNames': ['Human umbilical cord blood-derived mesenchymal stem cells'], 'armGroupLabels': ['Pneumostem®']}, {'name': 'Normal Saline', 'type': 'OTHER', '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': 'Won-Soon Park, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatrics, Samsung Medical Center'}, {'name': 'Ai-Rhan Kim', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neonatology, Asan Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipost Co Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}