Pulmonary Arterial Hypertension (PAH)Phase 1REVIVE-PHNCT07368088
PNEUMOSTEM® for Improving Respiratory Outcomes in Very Premature Infants Diagnosed With Early Pulmonary Arterial Hypertension
A Phase 1 study testing PNEUMOSTEM® in people with Pulmonary Arterial Hypertension (PAH) and Premature Infants, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 day to 14 days
- Conditions the study is for
- Pulmonary Arterial Hypertension (PAH), Premature Infants
- What is being tested?
- PNEUMOSTEM®
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2026to Jul 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site
Samsung Medical Center, 81, Irwon-ro, Gangnam-gu, Seoul, Republic of Korea
Seoul, 06351
Danbi Kim, +82-10-4601-9956, danbi03.kim@samsung.com
About this study
Official title: 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?
Read more
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
- Being tested
- PNEUMOSTEM®
- Medical subject headings
- Pulmonary Arterial Hypertension, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNEUMOSTEM®Biological
Also called Cell therapy product
PNEUMOSTEM® will be administered intratracheally as a single dose of 2.0x10000000 cells/kg on Day 1.
| Study group | Role | What they receive |
|---|---|---|
| PNEUMOSTEM® treatment arm | Experimental | PNEUMOSTEM® will be administered intratracheally as a single dose of 2.0x10,000,000 cells/kg on Day 1. Receives: Biological: PNEUMOSTEM® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time point(week) of complete reversal of cardiac shunt direction
Time from PNEUMOSTEM administration to complete reversal of intracardiac shunt from right-to-left to complete left-to-right direction, as assessed by echocardiography.
Measured: Biweekly from day after PNEUMOSTEM administration until postnatal day 28
Time to normalization of ventricular septal configuration
Time from PNEUMOSTEM administration to resolution of flattened interventricular septum or disappearance of D-shaped left ventricle at end-systole, as assessed by echocardiography.
Measured: Once between postnatal day 28 and PMA 36~40 weeks
Change in duration of pulmonary hypertension medication use
Change in duration of pulmonary hypertension medication use by medication type following PNEUMOSTEM administration compared to standard care. Duration will be measured in days for each medication type used to treat pulmonary hypertension.
Measured: Daily on PNEUMOSTEM administration day and the next day
Change in duration of mechanical ventilation
Change in total duration of mechalical ventilator use following PNEUMOSTEM andministration compared to standard care. Duration will be measured in days from initiation to discontinuation of mechanical ventilation.
Measured: Weekly at week 1 and week 2 after PNEUMOSTEM administration
Change in duration of supplemental oxygen therapy.
Change in total duration of supplemental oxygen use following PNEUMOSTEM administration compared to standard care. Duration will be measured in days from initiation to discontinuation of oxygen therapy.
Measured: Weekly at week 1 and week 2 after PNEUMOSTEM administration
Incidence of Bronchopulmonary Dysplasia(BPD)
Inicidence of bronchopulmonary dysplasia assessed according to standard diagnostic criteria(requirement for supplemental oxygen at 28 days of postnatal age and/or at 36 weeks postmenstrual age).
Measured: At postnatal day 28 and at between PMA 36~40 weeks
Severity of Bronchopulmonary Dysplasia(BPD)
Severity assessment of bronchopulmonary dysplasia categorized according to the definition of NIHCD 2001, NICHD 2018 and JENSEN 2019.
Measured: At postnatal day 28 and at between PMA 36~40 weeks
Incidence of Retinopathy of Prematurity(ROP)
Incidence of retinopathy of prematurity assessed by ophthalmologic examination according to the International Classification of Retinopathy of Prematurity.
Measured: Once at between PMA 36~40 weeks
Severity of Retinopathy of Prematurity(ROP)
Severity assessment of retinopathy of prematurity including staging(Stage 1~5), zone(Zone I, II, or III), and presence of pulse disease. Assessment of treatment requirements including lase photocoagulation, anti-VEGF injection, or surgical intervention.
Measured: Once at between PMA 36~40 weeks
Time point of brain injury ditection on Brain MRI
Time point of early detection of brain injury or neurodevelopmental abnormalities on brain MRI performed at postmenstrual age 36~40 weeks. Brain injuries assessed include intraventricular hemorrhage, periventricular leukomalacia, and other structural abnormalities.
Measured: Once at between PMA 36~40 weeks
Incidence of Respiratory-related mortality
Incidence of respiratory-related moratlity confirmed by medical records and information survey. Respiratory-related mortality is defined as death primarily attributed to respiratory failure, pulmonary hypertension, or complications of bronchopulmonary dysplasia.
Measured: From PNEUMOSTEM administration to PMA 36~40 weeks
Tiem point of respiratory-related mortality
Postnatal age(in days) at which respiratory-related death occurs in participants who experience this outcome. Time will be measured from PNEUMOSTEM administration to the date of death.
Measured: From PNEUMOSTEM administration to PMA 36~40 weeks
Secondary outcomes (18)
Incidence of Adverse Events Assessed by latest version of CTCAE
Incidence of adverse events graded according to the latest version of Common Terminology Criteria for Adverse Events(CTCAE). All adverse events will be recorded and categorized by system organ class and severity grade.
Measured: From PNEUMOSTEM administration to PMA 36~40 weeks
Change in anthropometric measurements - Weight
Change in body weight from baseline(PNEUMOSTEM administration day) measured in grams.
Measured: From PNEUMOSTEM administration to PMA 36~40 weeks
Change in anthropometric measurements - Head Circumference
Change in head circumference from baseline(PNEUMOSTEM administration day) measured in centimeters.
Measured: From PNEUMOSTEM administration to PMA 36~40 weeks
Abnormal findings on physical examination - Skin and Head/Neck
Incidence of clinically significant abnormal findings on physical examination of skin and head/neck regions.
Measured: From PNEUMOSTEM administration to PMA 36~40 weeks
Abnormal findings on physical examination - Cardiovascular and Respiratory systems
Incidence of clinically significant abnormal findings on physical examination of heart and lung systems.
Measured: From PNEUMOSTEM administration to PMA 36~40 weeks
Abnormal findings on physical examination - Abdomen and Genitalia
Incidence of clinically significant abnormal findings on physical examination of abdomen and genitalia.
Measured: From PNEUMOSTEM administration to PMA 36~40 weeks
Abnormal findings on physical examination - Nervous and Musculoskeletal systems
Incidence of clinically significant abnormal findings on physical examination of nervous system and musculoskeletal systems.
Measured: From PNEUMOSTEM administration to PMA 36~40 weeks
Change in vital signs - Blood pressure
Change in systolic and diastolic blood pressure from baseline(PNEUMOSTEM administration day) measured in mmHg.
Measured: From PNEUMOSTEM administration to PMA 36~40 weeks
Change in vital signs - Body temperature
Change in body temperature from baseline(PNEUMOSTEM administration day) measured in degrees celsius.
Measured: From PNEUMOSTEM administration to PMA 36~40 weeks
Change in vital signs - Heart rate
Change in heart rate(pulse) from baseline(PNEUMOSTEM administration day) measured in beats per minute.
Measured: From PNEUMOSTEM administration to PMA 36~40 weeks
Change in vital signs - Respiratory rate
Change in respiratory rate from baseline(PNEUMOSTEM administration day) measured in breaths per minute.
Measured: From PNEUMOSTEM administration to PMA 36~40 weeks
Change in vital signs - Oxygen saturation
Change in oxygen saturation(SpO2) from baseline(PNEUMOSTEM administration day) measure as percentage.
Measured: From PNEUMOSTEM administration to PMA 36~40 weeks
Abnormal laboratory values - Hematology
Incidence of clinically significant abnormal hematology laboratory values including white blood cell count(WBC), red blood cell count(RBC), hemoglobin(Hb), hematocrit(Hct), and platelet count(PLT).
Measured: Once at screening
Abnormal laboratory values - Blood chemistry
Incidence of clinically significant abnormal blood chemistry values including C-reactive protein(CRP) and other relevant biochemical markers.
Measured: At screening and within 24 hours after PNEUMOSTEM administration
Abnormal Electrocardiography findings
Incidence of clinically significant abnormal findings on continuous electrocardiography monitoring including arrhythmias, conduction abnormalities, or other cardiac electrical disturbances.
Measured: From PNEUMOSTEM administration to PMA 36~40 weeks
Incidence of infectious disease
Incidence of infectious disease identified by blood and tracheal aspirate(TTA) cultures with component analysis and pathogen identification.
Measured: At screening and weekly from baseline(PNEUMOSTEM adminitration day) to week 2
Abnormal blood gas analysis
Incidence of clinically significant abnormal blood gas analysis results for assessment of respiratory and metabolic status including PH, PaO2, PaCO2 and base excess.
Measured: From PNEUMOSTEM administration to postnatal day 28
Abnormal findings on chest x-ray
Incidence of clinically significant abnormal findings on chest radiography including evaluation for pleural effusion, pneumothorax, infiltrates, or other pulmonary abnormalities.
Measured: At screening, within 24 hours after PNEUMOSTEM adminitration, a week after PNEUMOSTEM administration, postnatal day 28 and at between PMA 36~40 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study startMar 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Arterial Hypertension (PAH)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single center, Single-arm study
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, So Yoon Ahn, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07368088
- Sponsor's protocol ID
- 2025-10-080
- Acronym
- REVIVE-PH
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 26 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07368088
- Acronym / sponsor ID
- REVIVE-PH / 2025-10-080
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single center, Single-arm study
| Arm | Type | Receives |
|---|---|---|
| PNEUMOSTEM® treatment arm | Experimental | Biological: PNEUMOSTEM®PNEUMOSTEM® will be administered intratracheally as a single dose of 2.0x10,000,000 cells/kg on Day 1. |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (9 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PNEUMOSTEM®Also: Cell therapy productPNEUMOSTEM® will be administered intratracheally as a single dose of 2.0x10000000 cells/kg on Day 1. | Biological | PNEUMOSTEM® treatment arm |
Primary outcome
Time point(week) of complete reversal of cardiac shunt direction
Time frame: Biweekly from day after PNEUMOSTEM administration until postnatal day 28
Time from PNEUMOSTEM administration to complete reversal of intracardiac shunt from right-to-left to complete left-to-right direction, as assessed by echocardiography.
Time to normalization of ventricular septal configuration
Time frame: Once between postnatal day 28 and PMA 36~40 weeks
Time from PNEUMOSTEM administration to resolution of flattened interventricular septum or disappearance of D-shaped left ventricle at end-systole, as assessed by echocardiography.
Change in duration of pulmonary hypertension medication use
Time frame: Daily on PNEUMOSTEM administration day and the next day
Change in duration of pulmonary hypertension medication use by medication type following PNEUMOSTEM administration compared to standard care. Duration will be measured in days for each medication type used to treat pulmonary hypertension.
Change in duration of mechanical ventilation
Time frame: Weekly at week 1 and week 2 after PNEUMOSTEM administration
Change in total duration of mechalical ventilator use following PNEUMOSTEM andministration compared to standard care. Duration will be measured in days from initiation to discontinuation of mechanical ventilation.
Change in duration of supplemental oxygen therapy.
Time frame: Weekly at week 1 and week 2 after PNEUMOSTEM administration
Change in total duration of supplemental oxygen use following PNEUMOSTEM administration compared to standard care. Duration will be measured in days from initiation to discontinuation of oxygen therapy.
Incidence of Bronchopulmonary Dysplasia(BPD)
Time frame: At postnatal day 28 and at between PMA 36~40 weeks
Inicidence of bronchopulmonary dysplasia assessed according to standard diagnostic criteria(requirement for supplemental oxygen at 28 days of postnatal age and/or at 36 weeks postmenstrual age).
Severity of Bronchopulmonary Dysplasia(BPD)
Time frame: At postnatal day 28 and at between PMA 36~40 weeks
Severity assessment of bronchopulmonary dysplasia categorized according to the definition of NIHCD 2001, NICHD 2018 and JENSEN 2019.
Incidence of Retinopathy of Prematurity(ROP)
Time frame: Once at between PMA 36~40 weeks
Incidence of retinopathy of prematurity assessed by ophthalmologic examination according to the International Classification of Retinopathy of Prematurity.
Severity of Retinopathy of Prematurity(ROP)
Time frame: Once at between PMA 36~40 weeks
Severity assessment of retinopathy of prematurity including staging(Stage 1~5), zone(Zone I, II, or III), and presence of pulse disease. Assessment of treatment requirements including lase photocoagulation, anti-VEGF injection, or surgical intervention.
Time point of brain injury ditection on Brain MRI
Time frame: Once at between PMA 36~40 weeks
Time point of early detection of brain injury or neurodevelopmental abnormalities on brain MRI performed at postmenstrual age 36~40 weeks. Brain injuries assessed include intraventricular hemorrhage, periventricular leukomalacia, and other structural abnormalities.
Incidence of Respiratory-related mortality
Time frame: From PNEUMOSTEM administration to PMA 36~40 weeks
Incidence of respiratory-related moratlity confirmed by medical records and information survey. Respiratory-related mortality is defined as death primarily attributed to respiratory failure, pulmonary hypertension, or complications of bronchopulmonary dysplasia.
Tiem point of respiratory-related mortality
Time frame: From PNEUMOSTEM administration to PMA 36~40 weeks
Postnatal age(in days) at which respiratory-related death occurs in participants who experience this outcome. Time will be measured from PNEUMOSTEM administration to the date of death.
18 secondary outcomes
Incidence of Adverse Events Assessed by latest version of CTCAE
Time frame: From PNEUMOSTEM administration to PMA 36~40 weeks
Change in anthropometric measurements - Weight
Time frame: From PNEUMOSTEM administration to PMA 36~40 weeks
Change in anthropometric measurements - Head Circumference
Time frame: From PNEUMOSTEM administration to PMA 36~40 weeks
Abnormal findings on physical examination - Skin and Head/Neck
Time frame: From PNEUMOSTEM administration to PMA 36~40 weeks
Abnormal findings on physical examination - Cardiovascular and Respiratory systems
Time frame: From PNEUMOSTEM administration to PMA 36~40 weeks
Abnormal findings on physical examination - Abdomen and Genitalia
Time frame: From PNEUMOSTEM administration to PMA 36~40 weeks
Abnormal findings on physical examination - Nervous and Musculoskeletal systems
Time frame: From PNEUMOSTEM administration to PMA 36~40 weeks
Change in vital signs - Blood pressure
Time frame: From PNEUMOSTEM administration to PMA 36~40 weeks
Change in vital signs - Body temperature
Time frame: From PNEUMOSTEM administration to PMA 36~40 weeks
Change in vital signs - Heart rate
Time frame: From PNEUMOSTEM administration to PMA 36~40 weeks
Change in vital signs - Respiratory rate
Time frame: From PNEUMOSTEM administration to PMA 36~40 weeks
Change in vital signs - Oxygen saturation
Time frame: From PNEUMOSTEM administration to PMA 36~40 weeks
Abnormal laboratory values - Hematology
Time frame: Once at screening
Abnormal laboratory values - Blood chemistry
Time frame: At screening and within 24 hours after PNEUMOSTEM administration
Abnormal Electrocardiography findings
Time frame: From PNEUMOSTEM administration to PMA 36~40 weeks
Incidence of infectious disease
Time frame: At screening and weekly from baseline(PNEUMOSTEM adminitration day) to week 2
Abnormal blood gas analysis
Time frame: From PNEUMOSTEM administration to postnatal day 28
Abnormal findings on chest x-ray
Time frame: At screening, within 24 hours after PNEUMOSTEM adminitration, a week after PNEUMOSTEM administration, postnatal day 28 and at between PMA 36~40 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PNEUMOSTEM® in people with Pulmonary Arterial Hypertension (PAH) and Premature Infants, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact So Yoon Ahn, M.D, Ph.D (+82-10-4038-0460, yoon.ahn.neo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time point(week) of complete reversal of cardiac shunt direction (time frame: Biweekly from day after PNEUMOSTEM administration until postnatal day 28). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2026.