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

Primary Purpose

Bronchopulmonary Dysplasia, Extremely Premature Infants, Severe BPD That Conventional Therapies Has Failed

Status
Unknown status
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
ucMSCs
Normal saline
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchopulmonary Dysplasia focused on measuring Bronchopulmonary dysplasia (BPD), Extremely premature infant, Mesenchymal stem cells (MSCs), umbilical cord

Eligibility Criteria

1 Week - 6 Months (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mesenchymal stem cells

Control

Arm 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

Normal saline

Outcomes

Primary Outcome Measures

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

Full Information

First Posted
September 11, 2010
Last Updated
September 22, 2010
Sponsor
China Medical University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01207869
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
July 2010 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
China Medical University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia, Extremely Premature Infants, Severe BPD That Conventional Therapies Has Failed, No Severe Congenital Anomalies, no Severe IVH Neither Cystic PVL
Keywords
Bronchopulmonary dysplasia (BPD), Extremely premature infant, Mesenchymal stem cells (MSCs), umbilical cord

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal stem cells
Arm Type
Experimental
Arm 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
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Normal saline
Intervention Type
Biological
Intervention Name(s)
ucMSCs
Intervention 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
Intervention Type
Other
Intervention Name(s)
Normal saline
Intervention Description
the same amount of ucMSCs suspension will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube
Primary Outcome Measure Information:
Title
The relations between the cytokine concentrations in the BAL fluid and PAP.
Description
To examine the relations between the cytokine concentrations in the BAL fluid and PAP.
Time Frame
Up to 20 weeks
Secondary Outcome Measure Information:
Title
The severity score of BPD ranging from 0 to 6 on the serial chest radiographs
Description
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.
Time Frame
6 months to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bai-Horng Su, MD, PhD
Organizational Affiliation
China Medical University Hospital,Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung,
ZIP/Postal Code
404
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

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