Overview

This trial is active, not recruiting.

Conditions bronchopulmonary dysplasia, extremely premature infants, severe bpd that conventional therapies has failed, no severe congenital anomalies, no severe ivh neither cystic pvl
Treatments ucmscs, normal saline
Phase phase 1
Sponsor China Medical University Hospital
Start date July 2010
End date June 2012
Trial size 10 participants
Trial identifier NCT01207869, DMR99-104

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (caregiver, investigator)
Primary purpose treatment
Arm
(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
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)
Normal saline
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

Primary Outcomes

Measure
The relations between the cytokine concentrations in the BAL fluid and PAP.
time frame: Up to 20 weeks

Secondary Outcomes

Measure
The severity score of BPD ranging from 0 to 6 on the serial chest radiographs
time frame: 6 months to 1 year

Eligibility Criteria

Male or female participants up to 6 months old.

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.

Additional Information

Official title Intratracheal Instillation of Umbilical Cord-derived Mesenchymal Stem Cells as a Rescue Treatment for Severe Bronchopulmonary Dysplasia
Principal investigator Bai-Horng Su, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2010.
Information provided to ClinicalTrials.gov by China Medical University Hospital.