Severe Bronchopulmonary DysplasiaPhase 2NCT03392467
PNEUMOSTEM for the Prevention and Treatment of Severe BPD in Premature Infants
A Phase 2 study testing PNEUMOSTEM in people with Severe Bronchopulmonary Dysplasia, run by Medipost Co Ltd. at 2 sites in South Korea.
Trial summary
This study is to evaluate the efficacy and safety of PNEUMOSTEM® for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia (Severe BPD) in Premature Infants. Half of subjects will receive PNEUMOSTEM, while the other half will receive a placebo. Read more about this study
- Who is it for?
- Ages Up to 13 days
- Conditions the study is for
- Severe Bronchopulmonary Dysplasia
- What is being tested?
- PNEUMOSTEM
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 13 Aug 2018to 18 Oct 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 Up to 13 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- at screening and randomization
- 23 weeks to < 25 weeks of gestational age
- 500g to 1,250g body weight at birth
- premature infant within postnatal 13 days of age
- use ventilator with ventilation rate >12 breaths/min or oxygen supply > 25%, or use high frequency ventilator (HFV)
- at IP administration
- premature infant within postnatal 5 to 14 days of age
- No improvement in ventilator setting 24 hours prior to administration of IP
Who cannot join
- subject with cyanotic congenital heart disease or non-cyanotic congenital heart disease that can cause heart failure
- subject with pulmonary hypoplasia, congenital diaphragmatic hernia, or serious lung malformation such as congenital cystic lung disease
- subject with chromosome disorder with serious malformation (i.e. Edward syndrome, patau syndrome, Down syndrome, etc.), severe congenital malformation (i.e. hydrocephalus, encephalocele, etc.), or severe congenital infection (i.e., herpes, toxoplasmosis, rubella, syphilis, AIDS, etc.)
- subject with serious sepsis as active infection or shock due to sepsis
- subject with grade 3 or 4 of bilateral intraventricular hemorrhage
- at screening, subject with active pulmonary hemorrhage or active air leak syndrome
Show all 11Show fewer
- subject who underwent/will undergo surgery within 72 hours before/after investigational product (IP) administration
- subject who is expected to be treated with surfactant within 24 hours prior to IP administration
- subject who is expected to be allergic to gentamicin (Birth mother's allergy for gentamicin will be confirmed).
- subject who have previously participated in other clinical trials
- subject who is considered ineligible by investigator due to other medical reasons
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of PNEUMOSTEM for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia in Premature Infants
This study is to evaluate the efficacy and safety of PNEUMOSTEM® for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia (Severe BPD) in Premature Infants. Half of subjects will receive PNEUMOSTEM, while the other half will receive a placebo.
Read the detailed description
Bronchopulmonary dysplasia (BPD) is a chronic lung disease in which premature infants and it results in significant morbidity and mortality. PNEUMOSTEM is intended to prevent and treat BPD by modulating inflammation and repairing damaged lung tissue in premature infants through paracrine effects.
- Conditions
- Severe Bronchopulmonary Dysplasia
- Being tested
- PNEUMOSTEM, Placebo
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNEUMOSTEMBiological
human umbilical cord blood-derived mesenchymal stem cells
PlaceboOther
normal saline
| Study group | Role | What they receive |
|---|---|---|
| PNEUMOSTEM | Experimental | human umbilical cord blood derived mesenchymal stem cell (hUCB-MSC) Receives: Biological: PNEUMOSTEM |
| Placebo | Placebo comparator | normal saline Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of subjects who have severe BPD or are dead
Percentage of subjects who have severe BPD or are dead
Measured: 36 weeks postmenstrual age (PMA)
Secondary outcomes (13)
Percentage of subjects who have moderate/severe BPD or are dead
Percentage of subjects who have moderate/severe BPD or are dead
Measured: 36 weeks PMA
Percentage of subjects by severity of BPD
Percentage of subjects by severity of BPD
Measured: prenatal 28 days/36 weeks PMA
Percentage of subjects in death due to lung disease
Percentage of subjects in death due to lung disease
Measured: prenatal 28 days/36 weeks PMA and study end timepoint
intubation duration
intubation duration
Measured: up to 24 weeks
ventilation duration
ventilation duration
Measured: up to 24 weeks
continuous positive airway pressure (CPAP) treatment duration
continuous positive airway pressure (CPAP) treatment duration
Measured: up to 24 weeks
treatment duration with supplemental oxygen
treatment duration with supplemental oxygen
Measured: up to 24 weeks
% of subjects treated with steroid for weaning ventilator
% of subjects treated with steroid for weaning ventilator
Measured: up to 24 weeks
Retinopathy of prematurity (ROP) with stage III or higher
number of subjects with ROP with stage III or higher
Measured: up to 24 weeks
number of subjects with retinopathy of prematurity that needs bevacizumab or laser therapy
number of subjects with retinopathy of prematurity that needs bevacizumab or laser therapy
Measured: up to 24 weeks
z-score
percentile for body weight, height, and head circumference
Measured: up to 24 weeks (visit 10)
days in hospitalization
days in hospitalization
Measured: up to 24 weeks
changes in tracheal suction fluid examination
changes in tracheal suction fluid examination
Measured: from screening to 7 days after IP administration (visit 5)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2018
- Study start13 Aug 2018
- Primary completion9 Jan 2024
- Study completion18 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Severe Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medipost Co Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wonsoon Park, Principal investigator, Samsung Medical CenterAirhan Kim, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392467
- Sponsor's protocol ID
- MP-CR-012
- Status last verified
- Mar 2024
- First submitted
- 20 Dec 2017
- Last updated
- 24 Jan 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ahn SY, Chang YS, Lee MH, Sung SI, Lee BS, Kim KS, Kim AR, Park WS. Stem cells for bronchopulmonary dysplasia in preterm infants: A randomized controlled phase II trial. Stem Cells Transl Med. 2021 Aug;10(8):1129-1137. doi: 10.1002/sctm.20-0330. Epub 2021 Apr 20.
PubMed 33876883
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of PNEUMOSTEM for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia in Premature Infants
- ClinicalTrials.gov ID
- NCT03392467
- Acronym / sponsor ID
- MP-CR-012
- Conditions
- Severe Bronchopulmonary Dysplasia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Medipost Co Ltd.Industry (pharma, biotech, devices)
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 18 Oct 2024 (actual)
- First posted
- 8 Jan 2018 (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.
This study is to evaluate the efficacy and safety of PNEUMOSTEM® for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia (Severe BPD) in Premature Infants. Half of subjects will receive PNEUMOSTEM, while the other half will receive a placebo.
Detailed description
Bronchopulmonary dysplasia (BPD) is a chronic lung disease in which premature infants and it results in significant morbidity and mortality. PNEUMOSTEM is intended to prevent and treat BPD by modulating inflammation and repairing damaged lung tissue in premature infants through paracrine effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNEUMOSTEM | Experimental | Biological: PNEUMOSTEMhuman umbilical cord blood derived mesenchymal stem cell (hUCB-MSC) |
| Placebo | Placebo comparator | Other: Placebonormal saline |
Who may qualify
- Ages
- Up to 13 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- at screening and randomization
- 23 weeks to < 25 weeks of gestational age
- 500g to 1,250g body weight at birth
- premature infant within postnatal 13 days of age
- use ventilator with ventilation rate >12 breaths/min or oxygen supply > 25%, or use high frequency ventilator (HFV)
Key exclusion criteria (11 listed)
- subject with cyanotic congenital heart disease or non-cyanotic congenital heart disease that can cause heart failure
- subject with pulmonary hypoplasia, congenital diaphragmatic hernia, or serious lung malformation such as congenital cystic lung disease
- subject with chromosome disorder with serious malformation (i.e. Edward syndrome, patau syndrome, Down syndrome, etc.), severe congenital malformation (i.e. hydrocephalus, encephalocele, etc.), or severe congenital infection (i.e., herpes, toxoplasmosis, rubella, syphilis, AIDS, etc.)
- subject with serious sepsis as active infection or shock due to sepsis
- subject with grade 3 or 4 of bilateral intraventricular hemorrhage
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 |
|---|---|---|
| PNEUMOSTEMhuman umbilical cord blood-derived mesenchymal stem cells | Biological | PNEUMOSTEM |
| Placebonormal saline | Other | Placebo |
Primary outcome
Percentage of subjects who have severe BPD or are dead
Time frame: 36 weeks postmenstrual age (PMA)
Percentage of subjects who have severe BPD or are dead
13 secondary outcomes
Percentage of subjects who have moderate/severe BPD or are dead
Time frame: 36 weeks PMA
Percentage of subjects by severity of BPD
Time frame: prenatal 28 days/36 weeks PMA
Percentage of subjects in death due to lung disease
Time frame: prenatal 28 days/36 weeks PMA and study end timepoint
intubation duration
Time frame: up to 24 weeks
ventilation duration
Time frame: up to 24 weeks
continuous positive airway pressure (CPAP) treatment duration
Time frame: up to 24 weeks
treatment duration with supplemental oxygen
Time frame: up to 24 weeks
% of subjects treated with steroid for weaning ventilator
Time frame: up to 24 weeks
Retinopathy of prematurity (ROP) with stage III or higher
Time frame: up to 24 weeks
number of subjects with retinopathy of prematurity that needs bevacizumab or laser therapy
Time frame: up to 24 weeks
z-score
Time frame: up to 24 weeks (visit 10)
days in hospitalization
Time frame: up to 24 weeks
changes in tracheal suction fluid examination
Time frame: from screening to 7 days after IP administration (visit 5)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Derived from this study: PubMed 33876883Ahn SY, Chang YS, Lee MH, Sung SI, Lee BS, Kim KS, Kim AR, Park WS. Stem cells for bronchopulmonary dysplasia in preterm infants: A randomized controlled phase II trial. Stem Cells Transl Med. 2021 Aug;10(8):1129-1137. doi: 10.1002/sctm.20-0330. Epub 2021 Apr 20.
- Individual participant dataSharing planned: Undecided
Related trials for Severe Bronchopulmonary Dysplasia
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
RecruitingObservational study
Multidimensional Phenotype Classification in Grade 3 Bronchopulmonary Dysplasia
Bronchopulmonary Dysplasia
RecruitingObservational study
Respiratory Exacerbations in Children With Bronchopulmonary Dysplasia (BPD): A Case-Control Study
Severe Respiratory Exacerbation
RecruitingObservational study
Characterization of Extracellular Vesicles From the Cord Blood of Extremely Preterm New Borns and Their Correlation With Severe Morbidity and Mortality
Intraventricular Hemorrhage, Pulmonary Hemorrhage
Recruiting
Gastric Feeding Versus Transpyloric Feeding in Infants with Severe Bronchopulmonary Dysplasia, a Crossover Study
Bronchopulmonary Dysplasia, Feeding Intolerance
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. This study is not recruiting at the moment.
Wonsoon Park principal investigator
Samsung Medical Center
Airhan Kim principal investigator
Asan Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PNEUMOSTEM in people with Severe Bronchopulmonary Dysplasia, run by Medipost Co Ltd. at 2 sites 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 8 inclusion and 11 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: finished, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of subjects who have severe BPD or are dead (time frame: 36 weeks postmenstrual age (PMA)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03392467, which also lists 1 linked publication.
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 24 Jan 2025.