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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01632475
Other study ID # MP-CR-006-F/U
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 2011
Est. completion date September 2026

Study information

Verified date April 2019
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 9
Est. completion date September 2026
Est. primary completion date September 2025
Accepts healthy volunteers No
Gender All
Age group 4 Months to 2 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Pneumostem®
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.

Locations

Country Name City State
Korea, Republic of Samsung Medical Center Seoul
Korea, Republic of Samsung Medical Center Seoul

Sponsors (2)

Lead Sponsor Collaborator
Samsung Medical Center Medipost Co Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of subjects with Adverse Drug Reaction Blood test, chest x-ray, physical exam at corrected age of 21 months (±3 months)
Secondary 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® 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.
at corrected age of 10 months (±2 months) and 21 months (±3 months)
Secondary Growth Body weight, Head circumference, Height : growth percentile Corrected gestational age of 4-6months, 8-12months, 18-24months
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