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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by China Medical University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01207869
First received: September 11, 2010
Last updated: September 22, 2010
Last verified: September 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Bronchopulmonary Dysplasia
Extremely Premature Infants
Severe BPD That Conventional Therapies Has Failed
No Severe Congenital Anomalies
no Severe IVH Neither Cystic PVL
 Biological: ucMSCs
Other: Normal saline
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Intratracheal Instillation of Umbilical Cord-derived Mesenchymal Stem Cells as a Rescue Treatment for Severe Bronchopulmonary Dysplasia

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • The relations between the cytokine concentrations in the BAL fluid and PAP. [ Time Frame: Up to 20 weeks ] [ Designated as safety issue: Yes ]
    To examine the relations between the cytokine concentrations in the BAL fluid and PAP.


Secondary Outcome Measures:
  • The severity score of BPD ranging from 0 to 6 on the serial chest radiographs [ Time Frame: 6 months to 1 year ] [ Designated as safety issue: Yes ]
    The severity score of BPD ranging from 0 to 6 on the serial chest radiographs will be graded by a single radiologist, without knowledge of the infant's identity or clinical course, using the roentgenographic severity scoring system.


Estimated Enrollment: 10
Study Start Date: July 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mesenchymal stem cells
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
 Biological: ucMSCs
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
Placebo Comparator: Control
Normal saline
 Other: Normal saline
the same amount of ucMSCs suspension will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207869

Locations
Taiwan
China Medical University Hospital
Taichung,, Taiwan, 404
Sponsors and Collaborators
China Medical University Hospital
Investigators
Principal Investigator: Bai-Horng Su, MD, PhD China Medical University Hospital, Taiwan
  More Information

No publications provided

Responsible Party: Bai-Horng Su, MD, PhD., Chairman of Department of Pediatrics, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01207869     History of Changes
Other Study ID Numbers: DMR99-104
Study First Received: September 11, 2010
Last Updated: September 22, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by China Medical University Hospital:
Bronchopulmonary dysplasia (BPD)
Extremely premature infant
Mesenchymal stem cells (MSCs)
umbilical cord

Additional relevant MeSH terms:
Congenital Abnormalities
Bronchopulmonary Dysplasia
Hyperplasia
Ventilator-Induced Lung Injury
Lung Injury
 Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013