PNEUMOSTEM for Very Premature Infants With Early Pulmonary Arterial Hypertension
Tests PNEUMOSTEM, given once into the windpipe, in very premature infants with pulmonary arterial hypertension.
Plain-language title generated from the registry record
Registry title: PNEUMOSTEM® for Improving Respiratory Outcomes in Very Premature Infants Diagnosed With Early Pulmonary Arterial Hypertension
Key facts
- Where
- Seoul, South KoreaSee the site
- Phase
- Phase 1
Where in South Korea
- Samsung Medical Center, 81, Irwon-ro, Gangnam-gu, Seoul, Republic of KoreaSeoul, South KoreaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Samsung Medical Center
- Trial code
- NCT07368088
- Record updated
- 26 January 2026
- Original description
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:Read full original descriptionShow less
A Clinical Study of Advanced Regenerative Medicine to Evaluate the Safety and Potential Efficacy of PNEUMOSTEM® for Improving Respiratory Outcomes in Very Premature Infants Diagnosed With Early Pulmonary Arterial Hypertension
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
Inclusion: 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.
Exclusion: 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 severe sepsis or shock due to active infection not adequately treated with antibiotics; 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 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 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.