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Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia

StatusUnknown
PhaseNot specified
Started
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Record status
This record was last updated April 9, 2019 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Changed Registry marked status Unknown (sponsor has not verified the record since Apr 2019); last known: Active, Not Recruiting
  2. Primary completion date: Sep 2017 to Sep 2025
    • Study completion date: Sep 2017 to Sep 2026
    v5
  3. Re-verified, no change to tracked fieldsv4
  4. Primary and study completion dates: Dec 2013 to Sep 2017v3
  5. Phase: Phase 1 to Not specifiedv2 Show 6 more changesShow less
    • Lead sponsor: Won Soon Park to Samsung Medical Center
    • Study sites: 1 to 2
    • Eligibility criteria shortened, about 249 words
    • Secondary endpoints: 1 to 2
    • Study description shortened, about 3 words
    • Collaborators expanded, about 3 words
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a long term follow-up study of the open label, single-center, phase I clinical trial to evaluate the safety of Pneumostem® in premature infants with BPD.
Trial Details
NCT Number NCT01632475
Lead Sponsor Samsung Medical Center
Collaborators: Medipost Co Ltd.
Conditions
(from sponsor)		 Bronchopulmonary Dysplasia
Related terms Bronchopulmonary Dysplasia, Hyperplasia, Infant, Newborn, Diseases, Infant, Premature, Diseases, Lung Diseases, Lung Injury, Pathologic Processes, Premature Birth, Ventilator-Induced Lung Injury
Enrollment 9 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov