Ignite Creation Date:
2025-12-24 @ 4:43 PM
Ignite Modification Date:
2026-02-23 @ 4:55 AM
Study NCT ID:
NCT02381366
Status:
COMPLETED
Last Update Posted:
2018-08-16
First Post:
2015-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD) - a US Study
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-14', 'studyFirstSubmitDate': '2015-02-15', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with adverse reactions for 84 days after treatment', 'timeFrame': '84 days'}], 'secondaryOutcomes': [{'measure': 'Number of participants with adverse reactions between 84 days after treatment and 20 months of corrected age', 'timeFrame': 'Between 84 days after treatment and 20 months of corrected age'}, {'measure': 'Incidence of moderate/severe BPD or death at 36 weeks postmenstrual age (PMA)', 'timeFrame': '36 weeks PMA'}, {'measure': 'Hospital Re-admission between 84 days after treatment until 20 months of corrected age', 'timeFrame': 'Between 84 days after treatment and 20 months of corrected age'}, {'measure': 'Bayley Scales of Infant and Toddler Development between 84 days after treatment until 20 months of corrected age', 'timeFrame': 'Between 84 days after treatment and 20 months of corrected age'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Mesenchymal Stem Cells', 'Human Umbilical Cord Blood', 'Premature Infants', 'Bronchopulmonary Dysplasia', 'Chronic Lung Disease', 'Cell Therapy'], 'conditions': ['Bronchopulmonary Dysplasia']}, 'referencesModule': {'references': [{'pmid': '30992220', 'type': 'DERIVED', 'citation': 'Powell SB, Silvestri JM. Safety of Intratracheal Administration of Human Umbilical Cord Blood Derived Mesenchymal Stromal Cells in Extremely Low Birth Weight Preterm Infants. J Pediatr. 2019 Jul;210:209-213.e2. doi: 10.1016/j.jpeds.2019.02.029. Epub 2019 Apr 13.'}]}, 'descriptionModule': {'briefSummary': 'PNEUMOSTEM® consists of ex vivo cultured allogeneic, unrelated, human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) and it is intended for use as a cellular therapy product for prevention of Bronchopulmonary Dysplasia (BPD). This study is an open-label, single-center, dose escalation study to evaluate of safety and efficacy of PNEUMOSTEM® in premature infants at high risk for BPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Days', 'minimumAge': '3 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A male or female infant whose postnatal age is 3 to 14 days, inclusive (for treatment between 5 and 14 days after birth)\n* A subject whose gestational age is between 23 and 28 weeks (23 weeks ≤ gestational age (GA) \\< 28 weeks)\n* A subject whose birth weight is between 500g and 1000g, inclusive\n* A subject who is intubated and receiving mechanical ventilation within 5-14 days after birth, with a fraction of inspired oxygen (FiO2) of 0.25 or greater at Screening\n* A subject who has had either a deterioration or no change in the setting of mechanical ventilation within the 24 hours before trial enrollment\n* A subject whose parent/guardian can give a written informed consent\n\nExclusion Criteria:\n\n* A subject who has a congenital heart defect, except for patent ductus arteriosus (PDA), atrial septal defect (ASD) or a small, restrictive ventricular septal defect (VSD)\n* A subject who has a serious malformation of the lung such as pulmonary hypoplasia/aplasia congenital diaphragmatic hernia, or other congenital lung anomaly\n* A subject who has a chromosomal abnormality (e.g., Trisomy 18, Trisomy 13 or Trisomy 21) or a severe congenital malformation (e.g., hydrocephalus and encephalocele, tracheo-esophageal fistula, abdominal wall defects, and major renal anomalies)\n* A subject who has had a severe congenital infectious disease (i.e., herpes, toxoplasmosis rubella, syphilis, HIV, etc.)\n* A subject who has evidence of severe sepsis or septic shock due to an active infection at Screening\n* A subject who underwent a surgical procedure within 72 hours before study drug administration or who is anticipated to have a surgical procedure within 72 hours before or following study drug administration\n* A subject who was administered surfactant within 24 hours before study drug administration\n* A subject who has had a bilateral grade 3 or 4 intracranial hemorrhage\n* A subject who has active pulmonary hemorrhage or an active air leak syndrome at Screening\n* A subject who is currently participating in any other interventional clinical trial\n* A subject who is, in the opinion of the Principal Investigator, considered inappropriate for the trial due to any reasons other than those listed above'}, 'identificationModule': {'nctId': 'NCT02381366', 'briefTitle': 'Safety and Efficacy of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD) - a US Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Medipost, Inc.'}, 'officialTitle': 'A Phase I/II, Open-Label Dose Escalation Trial to Evaluate the Safety and Efficacy of Two Dose Levels of PNEUMOSTEM® in Premature Infants at High Risk for Bronchopulmonary Dysplasia (BPD)', 'orgStudyIdInfo': {'id': 'MD-BPD-US001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PNEUMOSTEM®', 'description': 'Dose A: PNEUMOSTEM® 10 million cells per kg Dose B: PNEUMOSTEM® 20 million cells per kg', 'interventionNames': ['Biological: Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells']}], 'interventions': [{'name': 'Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells', 'type': 'BIOLOGICAL', 'otherNames': ['PNEUMOSTEM®'], 'description': 'Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells:\n\nDose A: 10 million cells per kg / Dose B: 20 million cells per kg', 'armGroupLabels': ['PNEUMOSTEM®']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Steven Powell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medipost, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Medipost Co Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}