NCT01828957

Randomized, Double-blind, Multi-center, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Pneumostem® Versus a Control Group for Treatment of Bronchopulmonary Dysplasia in Premature Infants

Completed Phase 2 Last updated 4 September 2019

What this trial tests

Phase 2 trial testing Pneumostem® in Bronchopulmonary Dysplasia in 69 participants. Completed in 1 August 2015.

Timeline

1 April 2013

Primary endpoint
1 May 2015

1 August 2015

Quick facts

Lead sponsor	Medipost Co Ltd.
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	69
Start date	1 April 2013
Primary completion	1 May 2015
Estimated completion	1 August 2015
Sites	2 locations across South Korea

Drugs / interventions tested

• Pneumostem®
• Normal Saline

Conditions studied

• Bronchopulmonary Dysplasia — all drugs for Bronchopulmonary Dysplasia →

Sponsor

Medipost Co Ltd. — full company profile →

Who can join

Adults 5 Days to 14 Days, 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.

• Incidence of BPD (moderate to severe) or mortality at 36 weeks PMA
  Time frame: 36 weeks PMA
  Incidence of BPD (moderate to severe) or mortality rate at 36 weeks PMA

Sponsor's own description

The objective of this study is to evaluate the efficacy and safety of a single intratracheal administration of Pneumostem® for treatment of Bronchopulmonary Dysplasia (BPD) in high-risk premature infants by comparing Pneumostem-treated group with a control group.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Bronchopulmonary dysplasia: clinical aspects and preventive and therapeutic strategies.
   Principi N, Di Pietro GM, Esposito S. · · 2018 · cited 170× · PMID 29463286 · DOI 10.1186/s12967-018-1417-7
2. First-In-Human Administration of Allogeneic Amnion Cells in Premature Infants With Bronchopulmonary Dysplasia: A Safety Study.
   Lim R, Malhotra A, Tan J, Chan ST, et al · · 2018 · cited 92× · PMID 30078207 · DOI 10.1002/sctm.18-0079
3. Stem cells for bronchopulmonary dysplasia in preterm infants: A randomized controlled phase II trial.
   Ahn SY, Chang YS, Lee MH, Sung SI, et al · · 2021 · cited 85× · PMID 33876883 · DOI 10.1002/sctm.20-0330
4. Present and Future of Bronchopulmonary Dysplasia.
   Bonadies L, Zaramella P, Porzionato A, Perilongo G, et al · · 2020 · cited 80× · PMID 32443685 · DOI 10.3390/jcm9051539
5. Stem cell-based therapy for neonatal lung disease: it is in the juice.
   Fung ME, Thébaud B. · · 2014 · cited 59× · PMID 24126817 · DOI 10.1038/pr.2013.176
6. Human amnion cells reverse acute and chronic pulmonary damage in experimental neonatal lung injury.
   Zhu D, Tan J, Maleken AS, Muljadi R, et al · · 2017 · cited 38× · PMID 29126435 · DOI 10.1186/s13287-017-0689-9
7. Two-year outcomes of infants enrolled in the first-in-human study of amnion cells for bronchopulmonary dysplasia.
   Malhotra A, Lim R, Mockler JC, Wallace EM. · · 2020 · cited 36× · PMID 31774236 · DOI 10.1002/sctm.19-0251
8. 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