Long-term Safety and Efficacy Follow-up Study of PNEUMOSTEM® in Patients Who Completed PNEUMOSTEM® Phase-I Study
1 other identifier
observational
8
1 country
1
Brief Summary
This is a 5-year long-term follow-up study of open label, single-center, phase I clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® in premature infants with bronchopulmonary dysplasia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Apr 2014
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2013
CompletedFirst Posted
Study publicly available on registry
December 30, 2013
CompletedStudy Start
First participant enrolled
April 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedSeptember 4, 2018
April 1, 2017
2.5 years
December 17, 2013
August 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects with adverse drug reactions
adverse drug reactions, clinically significant laboratory findings, vital signs, physical exam
60 months (corrected age)
Secondary Outcomes (4)
Respiratory outcomes
60 months (corrected age)
Survival
60 months (corrected age)
Z-score
60 months (corrected age)
Potential neurological development test outcomes
60 months (corrected age)
Study Arms (1)
Pneumostem®
Low Dose Group (3 subjects): 1.0 x 10\^7 cells/kg, High Dose Group (6 subjects): 2.0 x 10\^7 cells/kg Intervention: Biological: Pneumostem®
Interventions
A single intratracheal administration Low Dose Group (3 patients): 1.0 x 10\^7 cells/kg High Dose Group (6 patients): 2.0 x 10\^7 cells/kg \* The subjects were administered with Pneumostem in the earlier part of the Phase I study. No drug/biologics will be administered to any subject during this part of the study.
Eligibility Criteria
Infants who were enrolled in the 2-year follow-up study (NCT01632475) of phase 1 clinical trial for the safety and efficacy evaluations of PNEUMOSTEM® treatment in premature infants with bronchopulmonary dysplasia
You may qualify if:
- All infants who were enrolled in the 2-year follow-up study (NCT01632475) of phase 1 clinical trial for the safety and efficacy evaluations of PNEUMOSTEM® treatment in premature infants with bronchopulmonary dysplasia
- Infants with a written consent form signed by a parent or legal guardian
You may not qualify if:
- Infants whose parent or legal guardian does not consent to participate in this follow-up study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medipost Co Ltd.lead
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
Related Links
- Phase-I: 2 Year Follow-Up Safety and Efficacy Study of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
- Phase-I:Safety and Efficacy Evaluation of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia
- Phase-II: Efficacy and Safety Evaluation of Pneumostem® Versus a Control Group for Treatment of BPD in Premature Infants
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Won-Soon Park, MD, PhD
Samsung Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 17, 2013
First Posted
December 30, 2013
Study Start
April 1, 2014
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
September 4, 2018
Record last verified: 2017-04