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

Sponsor

China Medical University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT01207869

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	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 Design

Study Type:

Interventional

Anticipated Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jul 1, 2010

Anticipated Primary Completion Date :

Jun 1, 2012

Anticipated Study Completion Date :

Jul 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

The relations between the cytokine concentrations in the BAL fluid and PAP. [Up to 20 weeks]
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 [6 months to 1 year]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Week to 6 Months

Sexes Eligible for Study:

All

Accepts 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