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

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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01207869

Enrollment

Registered

2010-09-23

Start date

2010-07-31

Completion date

2012-07-31

Last updated

2010-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchopulmonary Dysplasia, Extremely Premature Infants, No Severe Congenital Anomalies, no Severe IVH Neither Cystic PVL, Severe BPD That Conventional Therapies Has Failed

Keywords

Bronchopulmonary dysplasia (BPD), Extremely premature infant, Mesenchymal stem cells (MSCs), umbilical cord

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.

Interventions

BIOLOGICALucMSCs

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

OTHERNormal saline

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

1 Weeks to 6 Months

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026