Follow-Up Study of Safety and Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01632475|
Recruitment Status : Active, not recruiting
First Posted : July 3, 2012
Last Update Posted : April 9, 2019
|Condition or disease||Intervention/treatment|
|Bronchopulmonary Dysplasia||Biological: Pneumostem®|
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|
|Actual Enrollment :||9 participants|
|Official Title:||Long Term Follow-Up Study of the Safety and Exploratory Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia|
|Actual Study Start Date :||September 2011|
|Estimated Primary Completion Date :||September 2025|
|Estimated Study Completion Date :||September 2026|
Low Dose Group (3 subjects): 1.0 x 10^7 cells/kg, High Dose Group (6 subjects): 2.0 x 10^7 cells/kg
A single intratracheal administration
Low Dose Group (3 patients): 1.0 x 10^7 cells/kg, High Dose Group (6 patients): 2 x 10^7 cells/kg
* The subjects were administered with Pneumostem® in the earlier part of the phase I study. No drugs/biologics are administered during this part of the study.
Other Name: Human umbilical cord blood-derived mesenchymal stem cells
- Number of subjects with Adverse Drug Reaction [ Time Frame: at corrected age of 21 months (±3 months) ]Blood test, chest x-ray, physical exam
- 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® [ Time Frame: at corrected age of 10 months (±2 months) and 21 months (±3 months) ]
Bayely test results of the 9 subjects who were treated with Pneumostem® during the early part of the Phase I study.
The results of Brain MRI study performed at corrected age of 18-24 months.
- Growth [ Time Frame: Corrected gestational age of 4-6months, 8-12months, 18-24months ]Body weight, Head circumference, Height : growth percentile
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01632475
|Korea, Republic of|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Samsung Medical Center|
|Seoul, Korea, Republic of|
|Principal Investigator:||Won-Soon Park, MD, PhD||Samsung Medical Center|