Trials / Completed
CompletedNCT01828957
Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 69 (actual)
- Sponsor
- Medipost Co Ltd. · Industry
- Sex
- All
- Age
- 5 Days – 14 Days
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pneumostem® | |
| OTHER | Normal Saline |
Timeline
- Start date
- 2013-04-01
- Primary completion
- 2015-05-01
- Completion
- 2015-08-01
- First posted
- 2013-04-11
- Last updated
- 2019-09-06
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01828957. Inclusion in this directory is not an endorsement.