Bronchopulmonary DysplasiaPhase 2NCT04003857
Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
A Phase 2 study testing PNEUMOSTEM® and normal saline in people with Bronchopulmonary Dysplasia and BPD, run by Medipost Co Ltd. at 2 sites in South Korea.
Trial summary
This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the Phase II trial (NCT03392467) will be followed-up until 60 months of corrected age Read more about this study
- Who is it for?
- Ages 6 to 60 months
- Conditions the study is for
- Bronchopulmonary Dysplasia, BPD
- What is being tested?
- PNEUMOSTEM® and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesSouth Korea
- Study dates
- 5 Jul 2019to 30 Jun 2027
- Phase
- Phase 2
- 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 6 to 60 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject who enrolled in phase 2 clinical trial of PNEUMOSTEM® to evaluate efficacy and safety, and were administered with investigational product
- Subject with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial
Who cannot join
- Subject whose parent or legal representative does not agree to participate in the study
- Subject who is considered inappropriate to participate in the study by the investigator
Trial locations and contacts
2 sites in 1 country.
About this study
This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the Phase II trial (NCT03392467) will be followed-up until 60 months of corrected age
Read the detailed description
Subjects who completed the initial stage of the Phase II clinical trial will be followed-up at 7 additional visits: 6, 12,18, 24 months corrected age, 36, 48, and 60 months after birth.
- Conditions
- Bronchopulmonary Dysplasia, BPD
- Being tested
- PNEUMOSTEM®, normal saline
- Keywords
- Human Umbilical Cord Blood Derived Mesenchymal Stem Cells, Bronchopulmonary dysplasia, Premature infants
- Medical subject headings
- Bronchopulmonary Dysplasia, 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 Human umbilical cord blood-derived mesenchymal stem cells
A single intratracheal administration of PNEUMOSTEM® (1.0 x 10^7 cells/kg)
normal salineBiological
A single intratracheal administration of normal saline
| Study group | Role | What they receive |
|---|---|---|
| PNEUMOSTEM® | Experimental | A single intratracheal administration of Pneumostem® (10.0 x 10^6 cells/kg) Receives: Biological: PNEUMOSTEM® |
| normal saline | Placebo comparator | A single intratracheal administration of normal saline Receives: Biological: normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Measured: 6 months corrected age
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Measured: 12 months corrected age
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection is recorded and compared with control group
Measured: 18 months corrected age
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Measured: 24 months corrected age
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Measured: 36 months after birth
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Measured: 39 months after birth
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Measured: 42 months after birth
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Measured: 45 months after birth
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Measured: 48 months after birth
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Measured: 51 months after birth
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Measured: 54 months after birth
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Measured: 57 months after birth
Respiratory outcome: Number of hospitalizations
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Measured: 60 months after birth
Secondary outcomes (9)
Mortality
check whether patient is alive or dead at evaluation time point
Measured: 6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth
Growth measured by Z-score
Growth measured by Z-score
Measured: 6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth
Neurological developmental status: Korean Developmental Screening Test for infants and children(K-DST)
Neurological developmental status on Korean Developmental Screening Test for infants and children(K-DST)
Measured: 6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth
Deafness or Blindness
Deafness: audiometry /Blindness: examination of extraocular muscle, fundus photography, optical biometry
Measured: 24 months corrected age
Bayley Scales of Infant and Toddler Development (Third Edition)
Scale: cognitive, motor, language, social-emotional, adaptive behavior
Measured: 18~24months corrected age, 36~42months after birth
Gross Motor Function Classification System for Cerebral Palsy
Gross Motor Function Classification System for Cerebral Palsy
Measured: 24 months corrected age
Number of adverse events
Number of adverse events
Measured: 6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth
Number of admissions to Emergency Room (ER)
Total number of admissions to Emergency Room (ER) and number of admission to Emergency Room (ER) due to respiratory infection at each evaluation time point
Measured: 6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth
Medical treatment records
whether or not, the patient is receiving medical treatment(use of oxygen, steroid, or bronchodilator, diuretics, Sildenafil) and if receiving treatment, the duration of the treatment at each evaluation time point
Measured: 6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start5 Jul 2019
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medipost Co Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Wonsoon Park, MD, PhD, Principal investigator, Department of Pediatrics, Samsung Medical CenterAi-Rhan Kim, MD, PhD, Principal investigator, Department of Neonatology, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003857
- Sponsor's protocol ID
- MP-CR-012-F/U
- Status last verified
- Feb 2025
- First submitted
- 19 Jun 2019
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Study of Safety and Efficacy in Subjects Who Completed PNEUMOSTEM® Phase II (MP-CR-012) Clinical Trial
- ClinicalTrials.gov ID
- NCT04003857
- Acronym / sponsor ID
- MP-CR-012-F/U
- Conditions
- Bronchopulmonary Dysplasia, BPD
- Keywords
- Human Umbilical Cord Blood Derived Mesenchymal Stem Cells, Bronchopulmonary dysplasia, Premature infants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Medipost Co Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Jul 2019 (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 is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the Phase II trial (NCT03392467) will be followed-up until 60 months of corrected age
Detailed description
Subjects who completed the initial stage of the Phase II clinical trial will be followed-up at 7 additional visits: 6, 12,18, 24 months corrected age, 36, 48, and 60 months after birth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNEUMOSTEM® | Experimental | Biological: PNEUMOSTEM®A single intratracheal administration of Pneumostem® (10.0 x 10^6 cells/kg) |
| normal saline | Placebo comparator | Biological: normal salineA single intratracheal administration of normal saline |
Who may qualify
- Ages
- 6 to 60 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Subject who enrolled in phase 2 clinical trial of PNEUMOSTEM® to evaluate efficacy and safety, and were administered with investigational product
- Subject with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial
Key exclusion criteria (2 listed)
- Subject whose parent or legal representative does not agree to participate in the study
- Subject who is considered inappropriate to participate in the study by the investigator
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: Human umbilical cord blood-derived mesenchymal stem cellsA single intratracheal administration of PNEUMOSTEM® (1.0 x 10^7 cells/kg) | Biological | PNEUMOSTEM® |
| normal salineA single intratracheal administration of normal saline | Biological | normal saline |
Primary outcome
Respiratory outcome: Number of hospitalizations
Time frame: 6 months corrected age
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Time frame: 12 months corrected age
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Time frame: 18 months corrected age
Total number of hospitalizations and the number of hospital stay due to respiratory infection is recorded and compared with control group
Respiratory outcome: Number of hospitalizations
Time frame: 24 months corrected age
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Time frame: 36 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Time frame: 39 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Time frame: 42 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Time frame: 45 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Time frame: 48 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Time frame: 51 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Time frame: 54 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Time frame: 57 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
Respiratory outcome: Number of hospitalizations
Time frame: 60 months after birth
Total number of hospitalizations and the number of hospital stay due to respiratory infection
9 secondary outcomes
Mortality
Time frame: 6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth
Growth measured by Z-score
Time frame: 6, 12, 18, 24 months corrected age, 36, 48, and 60 months after birth
Neurological developmental status: Korean Developmental Screening Test for infants and children(K-DST)
Time frame: 6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth
Deafness or Blindness
Time frame: 24 months corrected age
Bayley Scales of Infant and Toddler Development (Third Edition)
Time frame: 18~24months corrected age, 36~42months after birth
Gross Motor Function Classification System for Cerebral Palsy
Time frame: 24 months corrected age
Number of adverse events
Time frame: 6, 12, 18, 24 months corrected age,36, 48, and 60 months after birth
Number of admissions to Emergency Room (ER)
Time frame: 6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth
Medical treatment records
Time frame: 6, 12, 18, 24months corrected age, 36, 39, 42, 45, 48, 51, 54, 57 and 60 months after birth
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 7 Feb 2025.
- Individual participant dataSharing planned: No
Related trials for Bronchopulmonary Dysplasia
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Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
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Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
Not yet recruitingPhase 1/2
Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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, MD, PhD principal investigator
Department of Pediatrics, Samsung Medical Center
Ai-Rhan Kim, MD, PhD principal investigator
Department of Neonatology, 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® and normal saline in people with Bronchopulmonary Dysplasia and BPD, 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 7 Feb 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?
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?
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?
Respiratory outcome: Number of hospitalizations (time frame: 6 months corrected age). The study lists 13 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 7 Feb 2025.