Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia

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Brief Title

Intratracheal Umbilical Cord-derived Mesenchymal Stem Cells for Severe Bronchopulmonary Dysplasia

Official Title

Intratracheal Instillation of Umbilical Cord-derived Mesenchymal Stem Cells as a Rescue Treatment for Severe Bronchopulmonary Dysplasia

Brief Summary

      Mesenchymal stem cells (MSCs) have been reported to be effective to prevent alveolar growth
      arrest in experimental bronchopulmonary dysplasia (BPD). The aim is to treat the extremely
      premature infant with severe BPD to establish whether intratracheal instillation of umbilical
      cord-derived MSCs (ucMSCs) is safe and effective as a rescue treatment for severe BPD.

Study Phase

Phase 1

Study Type

Interventional

Primary Outcome

The relations between the cytokine concentrations in the BAL fluid and PAP.

Secondary Outcome

 The severity score of BPD ranging from 0 to 6 on the serial chest radiographs

Condition

Bronchopulmonary Dysplasia

Intervention

ucMSCs

Study Arms / Comparison Groups

 Mesenchymal stem cells
Description:  the ucMSCs suspension(3× 106 cells per kg of the patient's weight) will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube

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

10

Start Date

July 2010

Completion Date

July 2012

Primary Completion Date

June 2012

Eligibility Criteria

        Inclusion Criteria:

          -  severe BPD, defined by the National Institute of Child Health and Human Development
             workshop, who conventional therapies (including furosemide and theophylline, and HFO
             ventilation) has failed

        Exclusion Criteria:

          -  severe congenital anomalies

          -  severe intraventricular hemorrhage ≥ grade 3 or cystic periventricular leukomalacia.

Gender

All

Ages

N/A - 6 Months

Accepts Healthy Volunteers

No

Contacts

Bai-Horng Su, MD, PhD, ,

Location Countries

Taiwan

Location Countries

Taiwan

Administrative Informations

NCT ID

NCT01207869

Organization ID

DMR99-104

Study Sponsor

China Medical University Hospital

Study Sponsor

Bai-Horng Su, MD, PhD, Principal Investigator, China Medical University Hospital,Taiwan

Verification Date

September 2010