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

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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