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NCT01632475
Long Term Follow-Up Study of the Safety and Exploratory Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
trial testing Pneumostem® in Bronchopulmonary Dysplasia in 9 participants. Participants enrolled and being followed up; not accepting new ones.
1 September 2025
Quick facts
| Lead sponsor | Samsung Medical Center |
|---|---|
| Status | Active, enrolled |
| Study type | OBSERVATIONAL |
| Enrollment | 9 |
| Start date | 1 September 2011 |
| Primary completion | 1 September 2025 |
| Estimated completion | 1 September 2026 |
| Sites | 2 locations across South Korea |
Drugs / interventions tested
- Pneumostem®
Conditions studied
- Bronchopulmonary Dysplasia — all drugs for Bronchopulmonary Dysplasia →
Sponsor
Samsung Medical Center
Who can join
Adults 4 Months to 2, any sex, with Bronchopulmonary Dysplasia. 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.
-
Number of subjects with Adverse Drug Reaction
Time frame: at corrected age of 21 months (±3 months)
Blood test, chest x-ray, physical exam
Sponsor's own description
This is a long term follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with BPD.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Two-Year Follow-Up Outcomes of Premature Infants Enrolled in the Phase I Trial of Mesenchymal Stem Cells Transplantation for Bronchopulmonary Dysplasia.
Ahn SY, Chang YS, Kim JH, Sung SI, et al · · 2017 · cited 142× · PMID 28341525 · DOI 10.1016/j.jpeds.2017.02.061 -
Effects of Mesenchymal Stromal Cell-Derived Extracellular Vesicles in Lung Diseases: Current Status and Future Perspectives.
Guo H, Su Y, Deng F. · · 2021 · cited 42× · PMID 33211245 · DOI 10.1007/s12015-020-10085-8 -
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 -
Are all stem cells equal? Systematic review, evidence map, and meta-analyses of preclinical stem cell-based therapies for bronchopulmonary dysplasia.
Augustine S, Cheng W, Avey MT, Chan ML, et al · · 2020 · cited 32× · PMID 31746123 · DOI 10.1002/sctm.19-0193 -
Mesenchymal stem cells in the pathogenesis and treatment of bronchopulmonary dysplasia: a clinical review.
Simones AA, Beisang DJ, Panoskaltsis-Mortari A, Roberts KD. · · 2018 · cited 32× · PMID 28945702 · DOI 10.1038/pr.2017.237 -
Adult stem cells for acute lung injury: remaining questions and concerns.
Zhu YG, Hao Q, Monsel A, Feng XM, et al · · 2013 · cited 29× · PMID 23578018 · DOI 10.1111/resp.12093 -
Mesenchymal stromal/stem cells and bronchopulmonary dysplasia.
Zhang S, Mulder C, Riddle S, Song R, et al · · 2023 · cited 23× · PMID 37965579 · DOI 10.3389/fcell.2023.1247339
Verify or expand the search:
- PubMed search for NCT01632475
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Bronchopulmonary Dysplasia
Currently open trials in the same condition.
- NCT06589245 — Inhaled Ciclesonide Study in Preterm Infants · Phase 1 · recruiting
- NCT06512935 — Ventilator Pressure and Optimization of Compliance and Hemodynamics · NA · recruiting
- NCT06534359 — Transpyloric Versus Gastric Feeding in Bronchopulmonary Dysplasia · NA · recruiting
- NCT06808997 — Prospective Multicentre Mixed Methods Study to Explore Extubation Practices and Respiratory Outcomes in Extremely Preter · recruiting
- NCT06897839 — Efficacy and Safety of Zelpultide Alfa in Preterm Neonates at High Risk of Developing Bronchopulmonary Dysplasia (BPD) · Phase 2, PHASE3 · recruiting
Other Samsung Medical Center trials
Trials by the same sponsor.
- NCT07482865 — Routine Versus Provisional Distal Perfusion Catheter Placement in Patients Undergoing Mechanical Circulatory Support · NA · not yet recruiting
- NCT07467213 — Routine Use of Potassium Competitive Acid Blocker vs. Guideline-Directed Gastrointestinal Protection Strategy in Acute M · Phase 4 · not yet recruiting
- NCT07530913 — Effectiveness Analysis of a Rehabilitation Exercise Platform for Living Donor Liver Transplantation Patients · NA · enrolling by invitation
- NCT07500701 — Salvage Moderate Hypofractionated Versus Ultrahypofractionated Radiotherapy for Biochemical Recurrence After Radical Pro · Phase 3 · recruiting
- NCT07409441 — Korea Acute Myocardial Infarction Registry · not yet recruiting
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 NCT01632475 (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/NCT01632475.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing