NCT01897987

Follow-up Safety and Efficacy Evaluation on Subjects Who Completed the Initial Stage of PNEUMOSTEM® Phase-II Clinical Trial

Completed NA Last updated 5 August 2020

What this trial tests

NA trial testing Pneumostem® in Bronchopulmonary Dysplasia in 62 participants. Completed in 1 March 2020.

Timeline

1 January 2014

Primary endpoint
1 March 2020

1 March 2020

Quick facts

Lead sponsor	Medipost Co Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	62
Start date	1 January 2014
Primary completion	1 March 2020
Estimated completion	1 March 2020
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 7 Months to 7 Months, 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.

• Respiratory outcome: readmission rate and duration of the hospital stay due to respiratory infection
  Time frame: 6, 12, 18, 24, 36, 48, and 60 months, corrected age

Sponsor's own description

This is a follow-up study to investigate the long-term safety and efficacy of PNEUMOSTEM® versus placebo, for the treatment of BPD in premature infants. Subjects who participated in and completed the initial stage of the Phase II trial (NCT01828957) will be followed-up until 60 months of corrected age.

Publications & conference data

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

1. "Good things come in small packages": application of exosome-based therapeutics in neonatal lung injury.
   Willis GR, Mitsialis SA, Kourembanas S. · · 2018 · cited 41× · PMID 28985201 · DOI 10.1038/pr.2017.256
2. 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
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
4. 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
5. 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
6. 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
7. 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
8. Clinical applications of mesenchymal stromal cell-based therapies for pulmonary diseases: An Update and Concise Review.
   Chen X, Wang F, Huang Z, Wu Y, et al · · 2021 · cited 23× · PMID 34220313 · DOI 10.7150/ijms.59218