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Bronchopulmonary DysplasiaPhase 2NCT01828957

Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants

A Phase 2 study testing Pneumostem® and Normal Saline in people with Bronchopulmonary Dysplasia, run by Medipost Co Ltd. at 2 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The objective of this study is to evaluate the efficacy and safety of a single intratracheal administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk premature infants by comparing Pneumostem-treated group with a control group. Read more about this study

Who is it for?
Ages 5 to 14 days
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
69 participants
Where
2 sitesSouth Korea
Study dates
Apr 2013to Aug 2015
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 5 to 14 days
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Age: 5 - 14 days since birth
  • Fetal gestational age: ≥23 weeks and <29 weeks
  • Birth weight: ≥500g and ≤1250g
  • Premature infant of equal to or less than 2 weeks of age who is receiving a ventilator therapy at a rate of > 12 breath/min and > 25% oxygen
  • Patient whose ventilator setting has not been changed and who has shown aggravation of the illness within the 24 hours prior to the study enrollment
  • Patient with a written consent form signed by a legal representative or a parent upon explanation of the clinical trial

Who cannot join

  • Patient with concurrent cyanotic or acyanotic congenital heart diseases, except for patent ductus arteriosus
  • Patient with a concurrent severe lung malformation (i.e. Pulmonary hypoplasia, congenital diaphragmatic hernia, congenital cystic lung disease)
  • Patient with a concurrent severe lung malformation with chromosome anomalies (i.e. Edward syndrome, Patau syndrome, Down syndrome, etc) or severe congenital malformation (Hydrocephalus, Encephalocele, etc)
  • Patient with a concurrent severe congenital infection (i.e. Herpes, Toxoplasmosis, Rubella, Syphilis, AIDS, etc)
  • Patient withCRP > 30 mg/dL; Severe sepsis or shock
  • Patient who is scheduled for or expected to undergo a surgical procedure 72 hours prior to/following the administration of the study drug
Show all 12Show fewer
  • Patient who has been administered with a surfactant within the 24 hours prior to the administration of the study drug
  • Patient with severe intracranial hemorrhage ≥ grade 3 or 4
  • Patient with active pulmonary hemorrhage or active air leak syndrome at the time of screening
  • Patient with a history of participating in other clinical studies
  • Patient who is allergic to Gentamicin
  • Patient who is considered inappropriate to participate in the study by the investigator

Trial locations and contacts

2 sites in 1 country.

South Korea2 sites

  • Asan Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

Other trials in South Korea

About this study

Official title: Randomized, Double-blind, Multi-center, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Pneumostem® Versus a Control Group for Treatment of Bronchopulmonary Dysplasia in Premature Infants

The objective of this study is to evaluate the efficacy and safety of a single intratracheal administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk premature infants by comparing Pneumostem-treated group with a control group.

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 SalineOther

Study groups in NCT01828957
Study groupRoleWhat they receive
Pneumostem®ExperimentalA single intratracheal administration of Pneumostem® (1.0 x 10^7 cells/kg)
Receives: Biological: Pneumostem®
normal salinePlacebo comparatorA single intratracheal administration of normal saline
Receives: Other: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of BPD (moderate to severe) or mortality at 36 weeks PMA

    Incidence of BPD (moderate to severe) or mortality rate at 36 weeks PMA

    Measured: 36 weeks PMA

Secondary outcomes (16)

  1. Intubation duration

    Measured: 36 weeks PMA

  2. Incidence of BPD

    Measured: 28-days since birth

  3. Survival rate

    Measured: 28-days since birth, 36 weeks PMA, and termination of the trial

  4. Duration of ventilator dependence

    Measured: Week 24

  5. Duration of CPAP treatment

    Measured: Week 24

  6. Postnatal steroid use (%) for the purpose of ventilator weaning

    Measured: Week 24

  7. Cumulative duration of oxygen use

    Measured: Week 24

  8. Incidence of Retinopathy of Prematurity (ROP) of Grade III or more

    Measured: Week 24

  9. Retinopathy of Prematurity (ROP) that require treatment with avastin or laser

    Measured: Week 24

  10. Growth velocity (Z-score)

    Measured: Week 24

  11. Length of stay prior to the first discharge from the hospital

    Measured: duration of the hospital stay, an expected average of approximately 3 months since birth

  12. Incidence of adverse events

    Measured: Week 24

  13. Clinically significant laboratory findings

    Measured: Week 24

  14. Incidence of pneumothorax that require intubation

    Measured: Week 24

  15. Incidence of moderate to severe pulmonary hemorrhage

    Measured: Week 24

  16. Incidence of intraventricular hemorrhage of grade 3 or more

    Measured: Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2013 (estimated)
  2. Study startApr 2013
  3. Primary completionMay 2015
  4. Study completionAug 2015

Resources

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
69 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01828957
Sponsor's protocol ID
MP-CR-009
Status last verified
Apr 2017
First submitted
2 Apr 2013
Last updated
6 Sep 2019
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 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 6 inclusion and 12 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 6 Sep 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. 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?

Incidence of BPD (moderate to severe) or mortality at 36 weeks PMA (time frame: 36 weeks 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 NCT01828957, 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 6 Sep 2019.

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