None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : This clinical sttudy was designed to confirm the efficacy of administering PNEUMOSTEM®(Allogeneic umbilical cord blood-derived mesenchymal stem cells) to patients diagn
Sponsors
Samsung Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Premature infants within 2 weeks of birth with a gestational age of 28 weeks or less or birth weight of less than 1,250g who require continuous invasive mechanical ventilation 2) When diagnosed with early pulmonary arterial hypertension satisfying condition ? or ? up to 14 days after birth: ? When on or more of the following abnormal findings are present on echocardiography performed between 4 and 14 days after birth (findings at 1-3 days after birth correspond to early neonatal transition): a. Sytemic or suprasystemic pulmonary artery pressure >40mmHg(based on peak Doppler velocity of tricuspid regurgitation) b. Right-to-left or bidirectional shunt through patent ductus arteriosus, foramen ovale, or atrial septal defect c. Flattened interventricular septum or D-shaped left ventricle at end systole ? When receiving nitric oxide(NO) inhalation therapy for persistent pulmonary hypertension of the newborn(PPHN) within 3 days after birth
Exclusion criteria
Exclusion criteria: 1) Those witth cyanotic congenital heart defects or acyanotic congenital heart defects causing heart failure, excluding patent ductus arteriosus in premature infatns 2) Those with severe pulmonary malformations such as congenital diaphragmatic hernia or congenital cystic lung disease 3) Those who underwent surgery within 72 hours before or after administration of the investigational cell product, or those for whom surgery is anticipated 4) Those who received surfactant within 24 hours prior to administration of the investigattional cell product 5) Those with chromosomal abnormalities accompanied by severe malformations(such as Edwards syndrome, Patau syndrome, Down syndrome, etc.) and severe congenital malformations(such as hydrocephalus, encephalocele, etc.) 6) Those with severe congenital infectious diseases(such as herpes, toxoplasmosis, rubella, syphilis, AIDS, etc.) 7) Those with severe sepsis or shock due to active infection not adequately treated with antibiotics 8) Those who have a history of participation in other advanced regenerative medicine clinical studies or clinical trials 9) Others deemed inappropriate by tthe investigator to participate in this advanced regenerative medicine clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Respiratory-related assessments(duration of invasive/non-invasive mechanical ventilation, duration of oxygen therapy);Assessment of complication with bronchopulmonary dysplasia(BPD) and severity(Assessment of bronchopulmonary dysplasia incidence and severity evaluation);Assessment of retinopathy of prematurity(ROP) and severity(Assessment of retinopathy of prematurity stage, treatment, and surgical intervention);Confirmation of brain injury or other abnormal findings based on brain MRI examination and time point of occurrence(Brain injury assessment in cell therapy group, Timepoint of early diagnosis for neurodevelopmental and other abnormalities);Information collection at discharge(Confirmation of respiratory disease-related death and time of death);Improvement of pulmonary arterial hypertension and timing based on echocardiography;Reduction in duration of pulmonary arterial hypertension treatment medication use(duration of pulmonary arterial hypertension treatment medication use) | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events(Physical measurements, Physical examination, Vital signs, Laboratory tests, ECG, Blood culture, TTA culture and component analysis, Blood gas analysis, Chest X-ray) | — |
Countries
Korea, Republic of
Contacts
Public ContactDanbi Kim
Samsung Medical Center
Outcome results
None listed