Intracranial HemorrhagesNCT02673788
Follow-Up Study of Safety of Pneumostem® in Premature Infants With Intraventricular Hemorrhage
An observational study of Intracranial Hemorrhages and Mesenchymal Stem Cells, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
This is a follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with Intraventricular hemorrhage. Read more about this study
- Who is it for?
- Ages 6 months to 2 years
- Conditions the study is for
- Intracranial Hemorrhages, Mesenchymal Stem Cells, Newborn Infant
- What is being tested?
- observation without intervention in this follow up study
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2016to Dec 2023
- 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 6 months to 2 years
- All sexes
- No healthy volunteers
- Child
Study population: Paitents who enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.
Who may be able to join
- Patients who enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.
Who cannot join
- Patients who did not enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.
Trial locations and contacts
1 site in 1 country.
About this study
This is a follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with Intraventricular hemorrhage.
- Being tested
- observation without intervention in this follow up study
- Medical subject headings
- Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observation without intervention in this follow up studyOther
observation without intervention in this follow up study
What is being measured
The primary outcome is the main question the study is designed to answer.
newly developed brain tumor
Using brain MRI, it is to assess the risk of tumorigenicity of donor stem cells.
Measured: until 2 years old (corrected age)
Secondary outcomes (3)
Bayley score (MDI, PDI)
Measured: until 2 years old (corrected age)
Cerebral palsy
more than score 2 based on Gross Motor Function Classification System (GMFCS) score
Measured: until 2 years old (corrected age)
Developmental disability
scoring (category: gait, sitting, hand use, head control, communication, vision, hearing)
Measured: until 2 years old (corrected age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2016 (estimated)
- Study startJan 2016
- Primary completionDec 2022 (estimated)
- Study completionDec 2023 (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 Intracranial HemorrhagesStudies 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 (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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02673788
- Sponsor's protocol ID
- 2015-09-102
- Status last verified
- Apr 2019
- First submitted
- 26 Jan 2016
- Last updated
- 9 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Yang M, Ahn SY, Sung SI, Chang YS, Park WS. Five-year follow-up outcomes after phase 1 trial of mesenchymal stromal cells for periventricular hemorrhagic infarction in preterm infants. Stem Cells Transl Med. 2026 May 18;15(6):szag030. doi: 10.1093/stcltm/szag030.
PubMed 42241571
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
- Follow-Up Study of Safety of Pneumostem® in Premature Infants With Intraventricular Hemorrhage
- ClinicalTrials.gov ID
- NCT02673788
- Acronym / sponsor ID
- 2015-09-102
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 4 Feb 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.
This is a follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with Intraventricular hemorrhage.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 months to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Paitents who enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.
Key inclusion criteria (1 listed)
- Patients who enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.
Key exclusion criteria (1 listed)
- Patients who did not enrolled in the previous phase 1 clinical trial of Pneumostem transplantation for IVH.
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 |
|---|---|---|
| observation without intervention in this follow up studyobservation without intervention in this follow up study | Other | – |
Primary outcome
newly developed brain tumor
Time frame: until 2 years old (corrected age)
Using brain MRI, it is to assess the risk of tumorigenicity of donor stem cells.
3 secondary outcomes
Bayley score (MDI, PDI)
Time frame: until 2 years old (corrected age)
Cerebral palsy
Time frame: until 2 years old (corrected age)
Developmental disability
Time frame: until 2 years old (corrected age)
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 42241571Yang M, Ahn SY, Sung SI, Chang YS, Park WS. Five-year follow-up outcomes after phase 1 trial of mesenchymal stromal cells for periventricular hemorrhagic infarction in preterm infants. Stem Cells Transl Med. 2026 May 18;15(6):szag030. doi: 10.1093/stcltm/szag030.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Hemorrhages and Mesenchymal Stem Cells, 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 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 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. 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?
newly developed brain tumor (time frame: until 2 years old (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 NCT02673788, 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.