PNEUMOSTEM® for Improving Respiratory Outcomes in Very Premature Infants Diagnosed With Early Pulmonary Arterial Hypertension
Starting soon · Phase 1
Conditions studied: Pulmonary Arterial Hypertension (PAH), Premature Infants
In brief
The goal of this clinical trial is to evaluate the safety and potential efficacy of PNEUMOSTEM® for improving respiratory outcomes in very premature infants diagnosed with Early Pulmonary Arterial Hypertension. The main questions it aims to answer are: * In very premature infants diagnosed with early pulmonary arterial hypertension, will a single intratracheal administration of PNEUMOSTEM®(Allogeneic umbilical cord blood-derived mesenchymal stem cells) result in improvement of pulmonary arterial hypertension based on echocardiographic assessment? * In very premature infants diagnosed with early pulmonary arterial hypertension who show improvement of pulmonary arterial hypertension based on echocardiographic assessment following a single intratracheal administration of PNEUMOSTEM®(Allogeneic umbilical cord blood-derived mesenchymal stem cells), at what time point does this improvement occur? Participants will: * Single intratracheal dose of PNEUMOSTEM® at 2.0 x 10,000,000 cells/kg * Acute adverse event monitoring: 24 hours post-administration for safety assessment * Follow- up time points: Day 1(Baseline, PNEUMOSTEM® administration), Day 2, Week 1, Week 2, Postnatal Day 28, PMA 36\~40 weeks
Key facts
- Study ID
- NCT07368088
- Run by
- Samsung Medical Center
- People needed
- 12
- Starts
- 2026-03-01
- Expected to finish
- 2027-07-01
- Last updated by the study team
- 2026-01-26
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
- When diagnosed with early pulmonary arterial hypertension satisfying condition ① or ② 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):
- Sytemic or suprasystemic pulmonary artery pressure >40mmHg(based on peak Doppler velocity of tricuspid regurgitation)
- Right-to-left or bidirectional shunt through patent ductus arteriosus, foramen ovale, or atrial septal defect
- Flattened interventricular septum or D-shaped left ventricle at end systole ② When receiving nitric oxide(NO) inhalation therapy for persistent pulmonary hypertension of the newborn(PPHN) within 3 days after birth
You may not qualify if…
- Those witth cyanotic congenital heart defects or acyanotic congenital heart defects causing heart failure, excluding patent ductus arteriosus in premature infatns
- Those with severe pulmonary malformations such as congenital diaphragmatic hernia or congenital cystic lung disease
- Those who underwent surgery within 72 hours before or after administration of the investigational cell product, or those for whom surgery is anticipated
- Those who received surfactant within 24 hours prior to administration of the investigattional cell product
- 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.)
- Those with severe congenital infectious diseases(such as herpes, toxoplasmosis, rubella, syphilis, AIDS, etc.)
- Those with severe sepsis or shock due to active infection not adequately treated with antibiotics
- Those who have a history of participation in other advanced regenerative medicine clinical studies or clinical trials
- Others deemed inappropriate by tthe investigator to participate in this advanced regenerative medicine clinical study
Where it is running
- Samsung Medical Center, 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea — Seoul, South Korea
Full record on ClinicalTrials.gov
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