Mesenchymal Stromal CellsPhase 1NCT02274428
Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage
A Phase 1 study testing pneumostem in people with Mesenchymal Stromal Cells, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Phase 1 clinical trial for the safety and dose determination of Pneumostem (human umbilical cord blood derived mesenchymal stem cells) in the premature infants with intraventricular hemorrhage (IVH, grade 3-4) Read more about this study
- Who is it for?
- Ages 23 to 34 weeks
- Conditions the study is for
- Mesenchymal Stromal Cells
- What is being tested?
- pneumostem
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Dec 2016
- Phase
- Phase 1
- 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 23 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 23-34w
- IVH grade 3-4, confirmed with brain ultrasonogram
- within 7 days after IVH diagnosis
Who cannot join
- severe congenital anomaly
- intrauterine intracranial bleeding
- intracranial infection
- severe congenital infection
- active and uncontrolled infection, CRP>10mg/dl
- Platelet count <50,000/ml
- severe metabolic acidosis (PH<7.1, BE<-20)
Trial locations and contacts
1 site in 1 country.
About this study
Phase 1 clinical trial for the safety and dose determination of Pneumostem (human umbilical cord blood derived mesenchymal stem cells) in the premature infants with intraventricular hemorrhage (IVH, grade 3-4)
- Conditions
- Mesenchymal Stromal Cells
- Being tested
- pneumostem
- Keywords
- intraventricular hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumostemDrug
human umbilical cord blood derived mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| pneumostem group | Other | single arm, pneumostem treated infants Receives: Drug: pneumostem |
What is being measured
The primary outcome is the main question the study is designed to answer.
unsuspected death or anaphylactic shock
Measured: within 6 h after pneumostem transplantation
Secondary outcomes (1)
Death or hydrocephalus required shunt operation
outcome measurement time frame would not exceed 1 year after birth
Measured: First discharge home, maximum time frame : 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mesenchymal Stromal CellsStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
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
- Won Soon Park, M.D. Ph.D, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02274428
- Sponsor's protocol ID
- 2014-06-103
- Status last verified
- Apr 2017
- First submitted
- 2 Oct 2014
- Last updated
- 19 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial of PNEUMOSTEM® Treatment in Premature Infants With Intraventricular Hemorrhage
- ClinicalTrials.gov ID
- NCT02274428
- Acronym / sponsor ID
- 2014-06-103
- Conditions
- Mesenchymal Stromal Cells
- Keywords
- intraventricular hemorrhage
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- Feb 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 24 Oct 2014 (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.
Phase 1 clinical trial for the safety and dose determination of Pneumostem (human umbilical cord blood derived mesenchymal stem cells) in the premature infants with intraventricular hemorrhage (IVH, grade 3-4)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pneumostem group | Other | Drug: pneumostemsingle arm, pneumostem treated infants |
Who may qualify
- Ages
- 23 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 23-34w
- IVH grade 3-4, confirmed with brain ultrasonogram
- within 7 days after IVH diagnosis
Key exclusion criteria (7 listed)
- severe congenital anomaly
- intrauterine intracranial bleeding
- intracranial infection
- severe congenital infection
- active and uncontrolled infection, CRP>10mg/dl
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 |
|---|---|---|
| pneumostemhuman umbilical cord blood derived mesenchymal stem cells | Drug | pneumostem group |
Primary outcome
unsuspected death or anaphylactic shock
Time frame: within 6 h after pneumostem transplantation
1 secondary outcome
Death or hydrocephalus required shunt operation
Time frame: First discharge home, maximum time frame : 1 year
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 19 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Won Soon Park, M.D. Ph.D principal investigator
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 1 study testing pneumostem in people with Mesenchymal Stromal 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 3 inclusion and 7 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 19 Apr 2017. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
unsuspected death or anaphylactic shock (time frame: within 6 h after pneumostem transplantation). 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 19 Apr 2017.