Cell TransplantationPhase 2NCT02890953
Efficacy and Safety of Pneumostem® for IVH in Premature Infants (Phase 2a)
A Phase 2 study testing Pneumostem and Normal saline in people with Cell Transplantation, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The objective of this study is to evaluate the efficacy and safety of a single intraventricular administration of Pneumostem® for treatment of Intraventricular hemorrhage (IVH) in high-risk premature infants by comparing Pneumostem-treated group with a control group. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Cell Transplantation
- What is being tested?
- Pneumostem and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- 28 Mar 2017to Dec 2025
- 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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- IVH grade 3-4
- age : within postnatal day 28
- gestational age: 23-<34 weeks
Who cannot join
- Patient with severe congenital abnormalities
- Patient with antenatal brain hemorrhage
- Patient with asphyxia or Hypoxic ischemic encepalophathy
- Patient 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 with a history of participating in other clinical studies
- Patient who is considered inappropriate to participate in the study by the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of IVH in Premature Infants (Phase 2a)
The objective of this study is to evaluate the efficacy and safety of a single intraventricular administration of Pneumostem® for treatment of Intraventricular hemorrhage (IVH) in high-risk premature infants by comparing Pneumostem-treated group with a control group.
- Conditions
- Cell Transplantation
- Being tested
- Pneumostem, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PneumostemDrug
Also called Umbilical cord blood derived mesenchymal stem cells
direct intracerebroventricular injection of mesenchymal stem cells via ventricular tap
Normal salineDrug
direct intracerebroventricular injection of normal saline via ventricular tap
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Control group receives placebo medication (normal saline) Receives: Drug: Normal saline |
| MSC group | Experimental | MSC group receives mesenchymal stem cells transplantation (Pneumostem) Receives: Drug: Pneumostem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shunt or death
Shunt operation or death
Measured: 40 weeks of corrected age
Secondary outcomes (9)
Death
Death
Measured: at 2years
Developmental delay in gross motor function, 2y
Cerebral palsy, gross motor function classification system score ≥2
Measured: at 2years
Developmental delay Bayley -3
Bayley-3 scores <70
Measured: at 2years
Developmental delay in KDST, 2y
Korean Developmental Screening Test scores, below two standard deviations was classified as delayed
Measured: at 2 years
Language delay
Korean Sequenced Language Scale for Infant score
Measured: at 2 years, at 5 years
Developmental delay in KDST, 5y
Korean Developmental Screening Test scores, below two standard deviations was classified as delayed
Measured: at 5 years
Developmental delay in gross motor function
Cerebral palsy, gross motor function classification system score ≥2
Measured: at 2years
Developmental delay in gross motor function, 5y
Cerebral palsy, gross motor function classification system score ≥2
Measured: at 5years
epilepsy
epilepsy required anti-seizure medication or treatment
Measured: at 2 years, at 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study start28 Mar 2017
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cell TransplantationStudies 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
- 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
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Won Soon Park, Samsung Medical Center
- Investigators
- So Yoon Ahn, MD. Ph.D, Study director, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890953
- Sponsor's protocol ID
- 2016-06-005
- Status last verified
- Apr 2025
- First submitted
- 31 Aug 2016
- Last updated
- 13 Apr 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 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of IVH in Premature Infants (Phase 2a)
- ClinicalTrials.gov ID
- NCT02890953
- Acronym / sponsor ID
- 2016-06-005
- Conditions
- Cell Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 Sep 2016 (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.
The objective of this study is to evaluate the efficacy and safety of a single intraventricular administration of Pneumostem® for treatment of Intraventricular hemorrhage (IVH) in high-risk premature infants by comparing Pneumostem-treated group with a control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Normal salineControl group receives placebo medication (normal saline) |
| MSC group | Experimental | Drug: PneumostemMSC group receives mesenchymal stem cells transplantation (Pneumostem) |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- IVH grade 3-4
- age : within postnatal day 28
- gestational age: 23-<34 weeks
Key exclusion criteria (8 listed)
- Patient with severe congenital abnormalities
- Patient with antenatal brain hemorrhage
- Patient with asphyxia or Hypoxic ischemic encepalophathy
- Patient 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)
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 |
|---|---|---|
| PneumostemAlso: Umbilical cord blood derived mesenchymal stem cellsdirect intracerebroventricular injection of mesenchymal stem cells via ventricular tap | Drug | MSC group |
| Normal salinedirect intracerebroventricular injection of normal saline via ventricular tap | Drug | Control |
Primary outcome
Shunt or death
Time frame: 40 weeks of corrected age
Shunt operation or death
9 secondary outcomes
Death
Time frame: at 2years
Developmental delay in gross motor function, 2y
Time frame: at 2years
Developmental delay Bayley -3
Time frame: at 2years
Developmental delay in KDST, 2y
Time frame: at 2 years
Language delay
Time frame: at 2 years, at 5 years
Developmental delay in KDST, 5y
Time frame: at 5 years
Developmental delay in gross motor function
Time frame: at 2years
Developmental delay in gross motor function, 5y
Time frame: at 5years
epilepsy
Time frame: at 2 years, at 5 years
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 13 Apr 2025.
- Individual participant dataSharing planned: No
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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.
So Yoon Ahn, MD. Ph.D study director
Samsung Medical Center
1 site 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 Cell Transplantation, run by Samsung Medical Center at 1 site 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 3 inclusion and 8 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 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Shunt or death (time frame: 40 weeks of corrected age). 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 13 Apr 2025.