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

Phase 1

• Conditions: Bronchopulmonary Dysplasia; Extremely Premature Infants; Severe BPD That Conventional Therapies Has Failed; No Severe Congenital Anomalies; no Severe IVH Neither Cystic PVL
• Interventions: Biological: ucMSCs; Other: Normal saline

• Registration Number: NCT01207869
• Lead Sponsor: China Medical University Hospital

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 available

Study Timeline

• Study Start: 2010-07
• Status Verified: 2010-09
• Study First Submitted: 2010-09-11
• Study First Submitted QC: 2010-09-22
• Last Update Submitted: 2010-09-22
• Study First Posted: 2010-09-23
• Last Update Posted: 2010-09-23
• Primary Completion: 2012-06
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

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Exclusion Criteria

• severe congenital anomalies
• severe intraventricular hemorrhage ≥ grade 3 or cystic periventricular leukomalacia.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mesenchymal stem cells	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
Control	Normal saline	Normal saline

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

China Medical University Hospital; 🇨🇳 Taichung,, Taiwan