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

Tracking Information

First Received Date ^ICMJE

September 11, 2010

Last Updated Date

September 22, 2010

Start Date ^ICMJE

July 2010

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01207869 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Bronchopulmonary Dysplasia
Extremely Premature Infants
Severe BPD That Conventional Therapies Has Failed
No Severe Congenital Anomalies
no Severe IVH Neither Cystic PVL

Intervention ^ICMJE

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
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

Study Arm (s)

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

Intervention: Biological: ucMSCs
Placebo Comparator: Control
Normal saline

Intervention: Other: Normal saline

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2012

Estimated Primary Completion Date

June 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Both

Ages

up to 6 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Taiwan

Administrative Information

NCT Number ^ICMJE

NCT01207869

Other Study ID Numbers ^ICMJE

DMR99-104

Has Data Monitoring Committee

Yes

Responsible Party

Bai-Horng Su, MD, PhD., Chairman of Department of Pediatrics, China Medical University Hospital

Study Sponsor ^ICMJE

China Medical University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Bai-Horng Su, MD, PhD

China Medical University Hospital, Taiwan

Information Provided By

China Medical University Hospital

Verification Date

September 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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