NCT07368088: REVIVE-PH

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

Not yet recruiting Phase 1 Last updated 20 January 2026

What this trial tests

Phase 1 trial testing PNEUMOSTEM® in Pulmonary Arterial Hypertension (PAH) in 12 participants. Not yet recruiting.

Timeline

1 March 2026

Primary endpoint
1 December 2026

1 July 2027

Quick facts

Lead sponsor	Samsung Medical Center
Phase	Phase 1
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	12
Start date	1 March 2026
Primary completion	1 December 2026
Estimated completion	1 July 2027
Sites	1 location across South Korea

Drugs / interventions tested

• PNEUMOSTEM®

Conditions studied

• Pulmonary Arterial Hypertension (PAH) — all drugs for Pulmonary Arterial Hypertension (PAH) →
• Premature Infants — all drugs for Premature Infants →

Sponsor

Samsung Medical Center

Who can join

Adults 1 Day to 14 Days, any sex, with Pulmonary Arterial Hypertension (PAH) or Premature Infants. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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).

Sponsor's own 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:

* 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

Publications & conference data

No peer-reviewed publications indexed yet for this trial.