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NCT02673788
Follow-Up Study of Safety of Pneumostem® in Premature Infants With Intraventricular Hemorrhage
trial testing observation without intervention in this follow up study in Intracranial Hemorrhages in 9 participants. Status unknown.
1 December 2022
Quick facts
| Lead sponsor | Samsung Medical Center |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 9 |
| Start date | 1 January 2016 |
| Primary completion | 1 December 2022 |
| Estimated completion | 1 December 2023 |
| Sites | 1 location across South Korea |
Drugs / interventions tested
- observation without intervention in this follow up study
Conditions studied
- Intracranial Hemorrhages — all drugs for Intracranial Hemorrhages →
- Mesenchymal Stem Cells — all drugs for Mesenchymal Stem Cells →
- Newborn Infant — all drugs for Newborn Infant →
Sponsor
Samsung Medical Center
Who can join
Adults 6 Months to 2, any sex, with Intracranial Hemorrhages or Mesenchymal Stem Cells. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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.
Sponsor's own description
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.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Mesenchymal Stem Cells for Severe Intraventricular Hemorrhage in Preterm Infants: Phase I Dose-Escalation Clinical Trial.
Ahn SY, Chang YS, Sung SI, Park WS. · · 2018 · cited 117× · PMID 30133179 · DOI 10.1002/sctm.17-0219 -
Perinatal Hyperoxia and Developmental Consequences on the Lung-Brain Axis.
Obst S, Herz J, Alejandre Alcazar MA, Endesfelder S, et al · · 2022 · cited 37× · PMID 35251477 · DOI 10.1155/2022/5784146 -
Opportunities in posthemorrhagic hydrocephalus research: outcomes of the Hydrocephalus Association Posthemorrhagic Hydrocephalus Workshop.
Koschnitzky JE, Keep RF, Limbrick DD, McAllister JP, et al · · 2018 · cited 36× · PMID 29587767 · DOI 10.1186/s12987-018-0096-3 -
Mesenchymal stem cells for the prevention and treatment of bronchopulmonary dysplasia in preterm infants.
Pierro M, Thébaud B, Soll R. · · 2017 · cited 34× · PMID 29125893 · DOI 10.1002/14651858.cd011932.pub2 -
The Potential of Mesenchymal Stromal Cell as Therapy in Neonatal Diseases.
Liau LL, Al-Masawa ME, Koh B, Looi QH, et al · · 2020 · cited 32× · PMID 33251167 · DOI 10.3389/fped.2020.591693 -
Posttraumatic hydrocephalus: Recent advances and new therapeutic strategies.
Sanker V, Kundu M, El Kassem S, El Nouiri A, et al · · 2023 · cited 15× · PMID 38028696 · DOI 10.1002/hsr2.1713 -
Prevention, Reduction and Repair of Brain Injury of the Preterm Infant.
van Bel F, Vaes J, Groenendaal F. · · 2019 · cited 13× · PMID 30949060 · DOI 10.3389/fphys.2019.00181 -
Stem cell-based interventions for the prevention and treatment of germinal matrix-intraventricular haemorrhage in preterm infants.
Romantsik O, Bruschettini M, Moreira A, Thébaud B, et al · · 2019 · cited 7× · PMID 31549743 · DOI 10.1002/14651858.cd013201.pub2
Verify or expand the search:
- PubMed search for NCT02673788
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Samsung Medical Center trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02673788 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Samsung Medical Center
- Last refreshed: 7 April 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02673788.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing