Bronchopulmonary DysplasiaNCT01632475
Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
An observational study of Bronchopulmonary Dysplasia, run by Samsung Medical Center at 2 sites in South Korea.
Trial summary
This is a long term follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with BPD. Read more about this study
- Who is it for?
- Ages 4 months to 2 years
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Pneumostem®
- How many people
- 9 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Sep 2011to Sep 2026
- Phase
- Observational
- 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 4 months to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Infants who enrolled in the study of phase 1 clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia. (NCT01297205)
Who may be able to join
- all Infants who enrolled in the Phase 1 PNEUMOSTEM® clinical trial (NCT01297205)
Who cannot join
- Infants whose parent or legal guardian did not want to participate in the study
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Samsung Medical Center
Seoul, 135-710
Samsung Medical Center
Seoul
About this study
Official title: Long Term Follow-Up Study of the Safety and Exploratory Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
This is a long term follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with BPD.
Read the detailed description
Bronchopulmonary dysplasia (BPD) is the most common cause of death for premature newborns with low birth weights. In addition, many children who recover from the disease suffer from various complications such as prolonged hospitalization, pulmonary hypertension, and failure to thrive.
It has been reported that bone marrow-derived mesenchymal stem cells (BM-MSC) can differentiate into pulmonary epithelial and pulmonary endothelial cells. Some animal studies showed that BM-MSCs differentiate into bronchial cells and type 2 pneumocytes in rats with pneumonia and improve the fibrosis that occur after administration of bleomycin. Based on the findings, it is considered that mesenchymal stem cell therapy can help regenerate the damaged lung as well as BPD that cause lung inflammation, fibrosis, deficiency of type 2 pneumocytes, and so on.
PNEUMOSTEM® consists of human umbilical cord blood-derived mesenchymal stem cells and is intended to treat BPD in premature infants. This is a long term follow-up study of the earlier part of the phase I clinical trial.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Pneumostem®
- Keywords
- Human umbilical cord blood-derived mesenchymal stem cells, Premature infants, Bronchopulmonary dysplasia, Lung injury, Lung diseases, Hyperplasia, Ventilator-induced lung injury, Respiratory lung diseases, Pathologic Processes, Infant, Premature, Diseases, Infant, Newborn, Diseases
- Medical subject headings
- Bronchopulmonary Dysplasia, Premature Birth, Lung Injury, Lung Diseases, Hyperplasia, Ventilator-Induced Lung Injury, Pathologic Processes, Infant, Premature, Diseases
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
Low Dose Group (3 patients): 1.0 x 10^7 cells/kg, High Dose Group (6 patients): 2 x 10^7 cells/kg
- The subjects were administered with Pneumostem® in the earlier part of the phase I study. No drugs/biologics are administered during this part of the study.
| Study group | Role | What they receive |
|---|---|---|
| Pneumostem® | Low Dose Group (3 subjects): 1.0 x 10^7 cells/kg, High Dose Group (6 subjects): 2.0 x 10^7 cells/kg Receives: Biological: Pneumostem® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with Adverse Drug Reaction
Blood test, chest x-ray, physical exam
Measured: at corrected age of 21 months (±3 months)
Secondary outcomes (2)
Neurological development test outcome from the subjects who were treated with Pneumostem®, compared with the patients who suffered from the same conditions but not treated with Pneumostem®
Bayely test results of the 9 subjects who were treated with Pneumostem® during the early part of the Phase I study.
The results of Brain MRI study performed at corrected age of 18-24 months.
Measured: at corrected age of 10 months (±2 months) and 21 months (±3 months)
Growth
Body weight, Head circumference, Height : growth percentile
Measured: Corrected gestational age of 4-6months, 8-12months, 18-24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2012 (estimated)
- Study startSep 2011
- Primary completionSep 2025 (estimated)
- Study completionSep 2026 (estimated)
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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Medipost Co Ltd.
- Responsible party
- Principal investigator, Won Soon Park, Samsung Medical Center
- Investigators
- Won-Soon Park, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632475
- Sponsor's protocol ID
- MP-CR-006-F/U
- Status last verified
- Apr 2019
- First submitted
- 27 Jun 2012
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ahn SY, Chang YS, Kim JH, Sung SI, Park WS. Two-Year Follow-Up Outcomes of Premature Infants Enrolled in the Phase I Trial of Mesenchymal Stem Cells Transplantation for Bronchopulmonary Dysplasia. J Pediatr. 2017 Jun;185:49-54.e2. doi: 10.1016/j.jpeds.2017.02.061. Epub 2017 Mar 21.
PubMed 28341525
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Follow-Up Study of the Safety and Exploratory Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
- ClinicalTrials.gov ID
- NCT01632475
- Acronym / sponsor ID
- MP-CR-006-F/U
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- Human umbilical cord blood-derived mesenchymal stem cells, Premature infants, Bronchopulmonary dysplasia, Lung injury, Lung diseases, Hyperplasia, Ventilator-induced lung injury, Respiratory lung diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Medipost Co Ltd.
- Study start
- Sep 2011 (actual)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 3 Jul 2012 (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 long term follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with BPD.
Detailed description
Bronchopulmonary dysplasia (BPD) is the most common cause of death for premature newborns with low birth weights. In addition, many children who recover from the disease suffer from various complications such as prolonged hospitalization, pulmonary hypertension, and failure to thrive.
It has been reported that bone marrow-derived mesenchymal stem cells (BM-MSC) can differentiate into pulmonary epithelial and pulmonary endothelial cells. Some animal studies showed that BM-MSCs differentiate into bronchial cells and type 2 pneumocytes in rats with pneumonia and improve the fibrosis that occur after administration of bleomycin. Based on the findings, it is considered that mesenchymal stem cell therapy can help regenerate the damaged lung as well as BPD that cause lung inflammation, fibrosis, deficiency of type 2 pneumocytes, and so on.
PNEUMOSTEM® consists of human umbilical cord blood-derived mesenchymal stem cells and is intended to treat BPD in premature infants. This is a long term follow-up study of the earlier part of the phase I clinical trial.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pneumostem® | – | Biological: Pneumostem®Low Dose Group (3 subjects): 1.0 x 10^7 cells/kg, High Dose Group (6 subjects): 2.0 x 10^7 cells/kg |
Who may qualify
- Ages
- 4 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants who enrolled in the study of phase 1 clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia. (NCT01297205)
Key inclusion criteria (1 listed)
- all Infants who enrolled in the Phase 1 PNEUMOSTEM® clinical trial (NCT01297205)
Key exclusion criteria (1 listed)
- Infants whose parent or legal guardian did not want to participate in the study
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 Low Dose Group (3 patients): 1.0 x 10^7 cells/kg, High Dose Group (6 patients): 2 x 10^7 cells/kg * The subjects were administered with Pneumostem® in the earlier part of the phase I study. No drugs/biologics are administered during this part of the study. | Biological | Pneumostem® |
Primary outcome
Number of subjects with Adverse Drug Reaction
Time frame: at corrected age of 21 months (±3 months)
Blood test, chest x-ray, physical exam
2 secondary outcomes
Neurological development test outcome from the subjects who were treated with Pneumostem®, compared with the patients who suffered from the same conditions but not treated with Pneumostem®
Time frame: at corrected age of 10 months (±2 months) and 21 months (±3 months)
Growth
Time frame: Corrected gestational age of 4-6months, 8-12months, 18-24months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2019.
- Derived from this study: PubMed 28341525Ahn SY, Chang YS, Kim JH, Sung SI, Park WS. Two-Year Follow-Up Outcomes of Premature Infants Enrolled in the Phase I Trial of Mesenchymal Stem Cells Transplantation for Bronchopulmonary Dysplasia. J Pediatr. 2017 Jun;185:49-54.e2. doi: 10.1016/j.jpeds.2017.02.061. Epub 2017 Mar 21.
- Safety and Efficacy Evaluation of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary DysplasiaLink provided by the sponsor.
Related trials for Bronchopulmonary Dysplasia
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Controlled Remote Monitoring and Optimization of Oxygen Therapy in Preterm Infants
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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
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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.
Won-Soon Park, MD, PhD principal investigator
Samsung Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia, run by Samsung Medical Center 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 9 Apr 2019. 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. 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?
Results are not available in the source record.
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?
Number of subjects with Adverse Drug Reaction (time frame: at corrected age of 21 months (±3 months)). 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 NCT01632475, 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 9 Apr 2019.