NCT02890953

Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of IVH in Premature Infants (Phase 2a)

Active, enrolled Phase 2 Last updated 8 April 2025

What this trial tests

Phase 2 trial testing Pneumostem in Cell Transplantation in 22 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

28 March 2017

Primary endpoint
1 December 2025

1 December 2025

Quick facts

Lead sponsor	Samsung Medical Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	22
Start date	28 March 2017
Primary completion	1 December 2025
Estimated completion	1 December 2025
Sites	1 location across South Korea

Drugs / interventions tested

• Pneumostem — full drug profile →
• Normal saline

Conditions studied

• Cell Transplantation — all drugs for Cell Transplantation →

Sponsor

Samsung Medical Center

Who can join

Under 28 Days, any sex, with Cell Transplantation. 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.

• Shunt or death
  Time frame: 40 weeks of corrected age
  Shunt operation or death

Sponsor's own description

The objective of this study is to evaluate the efficacy and safety of a single intraventricular administration of Pneumostem® for treatment of Intraventricular hemorrhage (IVH) 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. 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
2. White matter injury in infants with intraventricular haemorrhage: mechanisms and therapies.
   Ballabh P, de Vries LS. · · 2021 · cited 106× · PMID 33504979 · DOI 10.1038/s41582-020-00447-8
3. Mesenchymal stromal/stem cells and their exosomes for restoration of spermatogenesis in non-obstructive azoospermia: a systemic review.
   Zhankina R, Baghban N, Askarov M, Saipiyeva D, et al · · 2021 · cited 49× · PMID 33823925 · DOI 10.1186/s13287-021-02295-9
4. 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
5. 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
6. The Potential of Stem Cell Therapy to Repair White Matter Injury in Preterm Infants: Lessons Learned From Experimental Models.
   Vaes JEG, Vink MA, de Theije CGM, Hoebeek FE, et al · · 2019 · cited 31× · PMID 31143126 · DOI 10.3389/fphys.2019.00540
7. Umbilical Cord Blood and Cord Tissue-Derived Cell Therapies for Neonatal Morbidities: Current Status and Future Challenges.
   Zhou L, McDonald C, Yawno T, Jenkin G, et al · · 2022 · cited 30× · PMID 35259278 · DOI 10.1093/stcltm/szab024
8. The Clinical Trials of Mesenchymal Stromal Cells Therapy.
   Kouchakian MR, Baghban N, Moniri SF, Baghban M, et al · · 2021 · cited 30× · PMID 34745268 · DOI 10.1155/2021/1634782