Brief Title
Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Official Title
Long Term Follow-Up Study of the Safety and Exploratory Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
Brief Summary
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.
Detailed Description
Bronchopulmonary dysplasia (BPD) is the most common cause of death for premature newborns with low birth weights. In addition, many children who recover from the disease suffer from various complications such as prolonged hospitalization, pulmonary hypertension, and failure to thrive. It has been reported that bone marrow-derived mesenchymal stem cells (BM-MSC) can differentiate into pulmonary epithelial and pulmonary endothelial cells. Some animal studies showed that BM-MSCs differentiate into bronchial cells and type 2 pneumocytes in rats with pneumonia and improve the fibrosis that occur after administration of bleomycin. Based on the findings, it is considered that mesenchymal stem cell therapy can help regenerate the damaged lung as well as BPD that cause lung inflammation, fibrosis, deficiency of type 2 pneumocytes, and so on. PNEUMOSTEM® consists of human umbilical cord blood-derived mesenchymal stem cells and is intended to treat BPD in premature infants. This is a long term follow-up study of the earlier part of the phase I clinical trial.
Study Type
Observational
Primary Outcome
Number of subjects with Adverse Drug Reaction
Secondary Outcome
Neurological development test outcome from the subjects who were treated with Pneumostem®, compared with the patients who suffered from the same conditions but not treated with Pneumostem®
Condition
Bronchopulmonary Dysplasia
Intervention
Pneumostem®
Study Arms / Comparison Groups
Pneumostem®
Description: Low Dose Group (3 subjects): 1.0 x 10^7 cells/kg, High Dose Group (6 subjects): 2.0 x 10^7 cells/kg
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
9
Start Date
September 2011
Completion Date
September 2026
Primary Completion Date
September 2025
Eligibility Criteria
Inclusion Criteria: - all Infants who enrolled in the Phase 1 PNEUMOSTEM® clinical trial (NCT01297205) Exclusion Criteria: - Infants whose parent or legal guardian did not want to participate in the study
Gender
All
Ages
4 Months - 2 Years
Accepts Healthy Volunteers
No
Contacts
Won-Soon Park, MD, PhD, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT01632475
Organization ID
MP-CR-006-F/U
Responsible Party
Principal Investigator
Study Sponsor
Samsung Medical Center
Collaborators
Medipost Co Ltd.
Study Sponsor
Won-Soon Park, MD, PhD, Principal Investigator, Samsung Medical Center
Verification Date
April 2019