Trials / Active Not Recruiting
Active Not RecruitingNCT02890953
Efficacy and Safety of Pneumostem® for IVH in Premature Infants (Phase 2a)
Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of IVH in Premature Infants (Phase 2a)
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- Sponsor
- Samsung Medical Center · Academic / Other
- Sex
- All
- Age
- 28 Days
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Pneumostem | direct intracerebroventricular injection of mesenchymal stem cells via ventricular tap |
| DRUG | Normal saline | direct intracerebroventricular injection of normal saline via ventricular tap |
Timeline
- Start date
- 2017-03-28
- Primary completion
- 2025-12-01
- Completion
- 2025-12-01
- First posted
- 2016-09-07
- Last updated
- 2025-04-13
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02890953. Inclusion in this directory is not an endorsement.