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

Bronchopulmonary Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01207869
• Other study ID #: DMR99-104
• Status: Active, not recruiting
• Phase: Phase 1
• First received: September 11, 2010
• Last updated: September 22, 2010
• Start date: July 2010
• Est. completion date: July 2012

Study information

• Verified date: September 2010
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 10
• Est. completion date: July 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

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

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

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung,

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	The severity score of BPD ranging from 0 to 6 on the serial chest radiographs	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.	6 months to 1 year	Yes