Trials / Completed
CompletedNCT01897987
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed PNEUMOSTEM® Phase-II Clinical Trial
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed the Initial Stage of PNEUMOSTEM® Phase-II Clinical Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 62 (actual)
- Sponsor
- Medipost Co Ltd. · Industry
- Sex
- All
- Age
- 7 Months – 7 Months
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Subjects who completed the initial stage of the Phase II clinical trial will be followed-up at 7 additional visits: corrected age of 6, 12,18, 24, 36, 48, and 60 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Pneumostem® | |
| BIOLOGICAL | normal saline |
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2020-03-01
- Completion
- 2020-03-01
- First posted
- 2013-07-12
- Last updated
- 2020-08-07
Locations
2 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01897987. Inclusion in this directory is not an endorsement.