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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01632475
First Posted: July 3, 2012
Last Update Posted: October 14, 2016
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.
Collaborator:
Medipost Co Ltd.
Information provided by (Responsible Party):
Won Soon Park, Samsung Medical Center
  Purpose
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.

Condition Intervention Phase
Bronchopulmonary Dysplasia Biological: Pneumostem® Phase 1

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long Term Follow-Up Study of the Safety and Exploratory Efficacy of Pneumostem® in Premature Infants With Bronchopulmonary Dysplasia

Resource links provided by NLM:


Further study details as provided by Won Soon Park, Samsung Medical Center:

Primary Outcome Measures:
  • Number of subjects with Adverse Drug Reaction [ Time Frame: at corrected age of 21 months (±3 months) ]
    Blood test, chest x-ray, physical exam


Secondary Outcome Measures:
  • 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


Enrollment: 9
Study Start Date: September 2011
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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
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.

Other Name: Human umbilical cord blood-derived mesenchymal stem cells

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   4 Months to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Infants who enrolled in the study of phase 1 clinical trial to evaluate the safety and efficacy of PNEUMOSTEM® Treatment in Premature Infants With Bronchopulmonary Dysplasia. (NCT01297205)
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
  Contacts and Locations
Information from the National Library of Medicine

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


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Medipost Co Ltd.
Investigators
Principal Investigator: Won-Soon Park, MD, PhD Samsung Medical Center
  More Information

Additional Information:
Responsible Party: Won Soon Park, Professor of Pediatrics, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01632475     History of Changes
Other Study ID Numbers: MP-CR-006-F/U
First Submitted: June 27, 2012
First Posted: July 3, 2012
Last Update Posted: October 14, 2016
Last Verified: October 2016

Keywords provided by Won Soon Park, Samsung Medical Center:
Human umbilical cord blood-derived mesenchymal stem cells
Premature infants
Bronchopulmonary dysplasia
Lung injury
Lung diseases
Hyperplasia
Ventilator-induced lung injury
Respiratory lung diseases
Pathologic Processes
Infant, Premature, Diseases
Infant, Newborn, Diseases

Additional relevant MeSH terms:
Premature Birth
Hyperplasia
Bronchopulmonary Dysplasia
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Pathologic Processes
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases