Bronchopulmonary DysplasiaNCT01897987
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial
A study testing Pneumostem® and normal saline in people with Bronchopulmonary Dysplasia, 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 (NCT01828957) will be followed-up until 60 months of corrected age. Read more about this study
- Who is it for?
- Ages 7 to 7 months
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Pneumostem® and normal saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Jan 2014to Mar 2020
- Phase
- Interventional
- 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 7 to 7 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subject who completed the safety and efficacy evaluations in Pneumostem Phase II clinical trial
- 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
Official title: Follow-up Safety and Efficacy Evaluation on Subjects Who Completed the Initial Stage of PNEUMOSTEM® Phase-II Clinical Trial
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 (NCT01828957) 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: corrected age of 6, 12,18, 24, 36, 48, and 60 months.
- Conditions
- Bronchopulmonary Dysplasia
- 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
normal salineBiological
| Study group | Role | What they receive |
|---|---|---|
| Pneumostem® | Experimental | A single intratracheal administration of Pneumostem® (1.0 x 10^7 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: readmission rate and duration of the hospital stay due to respiratory infection
Measured: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
Secondary outcomes (9)
Whether the subject is receiving medical treatments and if so, duration of the treatment (use of oxygen, steroid, or brochodilator)
Measured: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
Number of admissions to Emergency Room
Total number of admissions to Emergency Room and number of admissions to Emergency Room due to resiratory problems
Measured: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
Survival
Measured: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
Growth measured by Z-score
Measured: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
Neurological developmental status on K-ASQ, Bayley Scale, Gross Motor Function Classification System (GMFCS) for Cerebral Palsy
Measured: 24 months, corrected age
Deafness or Blindness
Measured: 24 months, corrected age
Number of adverse events
Measured: 6, 12, 24,36, 48, and 60 months, corrected age
Significant changes in vital signs
Measured: 6, 12, 24, 36, 48, and 60 months, corrected age
Significant changes in physical exam
Measured: 6, 12, 24, 36, 48, and 60 months, corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2013 (estimated)
- Study startJan 2014
- Primary completionMar 2020
- Study completionMar 2020
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 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 62 participants (actual)
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
- NCT01897987
- Sponsor's protocol ID
- MP-CR-009-FU
- Status last verified
- Aug 2020
- First submitted
- 4 Jul 2013
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ahn SY, Chang YS, Lee MH, Sung S, Kim AR, Park WS. Five-year follow-up of phase II trial of stromal cells for bronchopulmonary dysplasia. Thorax. 2023 Nov;78(11):1105-1110. doi: 10.1136/thorax-2022-219622. Epub 2023 Aug 21.
PubMed 37604693
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow-up Safety and Efficacy Evaluation on Subjects Who Completed the Initial Stage of PNEUMOSTEM® Phase-II Clinical Trial
- ClinicalTrials.gov ID
- NCT01897987
- Acronym / sponsor ID
- MP-CR-009-FU
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Human Umbilical Cord Blood Derived Mesenchymal Stem Cells, Bronchopulmonary dysplasia, Premature infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Medipost Co Ltd.Industry (pharma, biotech, devices)
- Study start
- Jan 2014 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 12 Jul 2013 (estimated)
- 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 (NCT01828957) 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: corrected age of 6, 12,18, 24, 36, 48, and 60 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pneumostem® | Experimental | Biological: Pneumostem®A single intratracheal administration of Pneumostem® (1.0 x 10^7 cells/kg) |
| normal saline | Placebo comparator | Biological: normal salineA single intratracheal administration of normal saline |
Who may qualify
- Ages
- 7 to 7 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Subject who completed the safety and efficacy evaluations in Pneumostem Phase II clinical trial
- 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 cells | Biological | Pneumostem® |
| normal saline | Biological | normal saline |
Primary outcome
Respiratory outcome: readmission rate and duration of the hospital stay due to respiratory infection
Time frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
9 secondary outcomes
Whether the subject is receiving medical treatments and if so, duration of the treatment (use of oxygen, steroid, or brochodilator)
Time frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
Number of admissions to Emergency Room
Time frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
Survival
Time frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
Growth measured by Z-score
Time frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age
Neurological developmental status on K-ASQ, Bayley Scale, Gross Motor Function Classification System (GMFCS) for Cerebral Palsy
Time frame: 24 months, corrected age
Deafness or Blindness
Time frame: 24 months, corrected age
Number of adverse events
Time frame: 6, 12, 24,36, 48, and 60 months, corrected age
Significant changes in vital signs
Time frame: 6, 12, 24, 36, 48, and 60 months, corrected age
Significant changes in physical exam
Time frame: 6, 12, 24, 36, 48, and 60 months, corrected age
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 7 Aug 2020.
- Derived from this study: PubMed 37604693Ahn SY, Chang YS, Lee MH, Sung S, Kim AR, Park WS. Five-year follow-up of phase II trial of stromal cells for bronchopulmonary dysplasia. Thorax. 2023 Nov;78(11):1105-1110. doi: 10.1136/thorax-2022-219622. Epub 2023 Aug 21.
Related trials for Bronchopulmonary Dysplasia
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Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
BPD - Bronchopulmonary Dysplasia, Pulmonary Hypertension
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Little Lungs Study
Invasive Mechanical Ventilation, Severe Respiratory Distress Syndrome
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Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
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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 study testing Pneumostem® and normal saline in people with 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 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: finished, as of the sponsor's last update on 7 Aug 2020. 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.
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?
Respiratory outcome: readmission rate and duration of the hospital stay due to respiratory infection (time frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age). 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 NCT01897987, 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 7 Aug 2020.