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

NCT01207869 | Unknown Phase 1 DMC

• 1 other identifier: DMR99-104
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 20 weeks

Secondary Outcomes (1)

• The severity score of BPD ranging from 0 to 6 on the serial chest radiographs

  6 months to 1 year

Study Arms (2)

Mesenchymal stem cells

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

Normal saline

Other: Normal saline

Interventions

ucMSCs BIOLOGICAL

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

Mesenchymal stem cells

Normal saline OTHER

the same amount of ucMSCs suspension will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube

Control

Eligibility Criteria

• Age: 1 Week - 6 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• China Medical University Hospital: lead

Study Sites (1)

China Medical University Hospital

Taichung, 404, Taiwan

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Bai-Horng Su, MD, PhD

  China Medical University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2010
• First Posted: September 23, 2010
• Study Start: July 1, 2010
• Primary Completion: June 1, 2012
• Study Completion: July 1, 2012
• Last Updated: September 23, 2010

Record last verified: 2010-09

Locations

TW (1)