PNEUMOSTEM for the Prevention and Treatment of Severe BPD in Premature Infants

Severe Bronchopulmonary Dysplasia Clinical Trial

Official title:

A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of PNEUMOSTEM for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia in Premature Infants

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03392467
• Other study ID #: MP-CR-012
• Status: Recruiting
• Phase: Phase 2
• Start date: August 13, 2018
• Est. completion date: March 2024

Study information

• Verified date: March 2023
• Source: Medipost Co Ltd.
• Contact: Eunyoung Lee
• Phone: 82234656748
• Email: ley0113[@]medi-post.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the efficacy and safety of PNEUMOSTEM® for the Prevention and Treatment of Severe Bronchopulmonary Dysplasia (Severe BPD) in Premature Infants. Half of subjects will receive PNEUMOSTEM, while the other half will receive a placebo.

Description:

Bronchopulmonary dysplasia (BPD) is a chronic lung disease in which premature infants and it results in significant morbidity and mortality. PNEUMOSTEM is intended to prevent and treat BPD by modulating inflammation and repairing damaged lung tissue in premature infants through paracrine effects.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 13 Days

Eligibility

Inclusion Criteria:

at screening and randomization

1. 23 weeks to < 25 weeks of gestational age

2. 500g to 1,250g body weight at birth

3. premature infant within postnatal 13 days of age

4. use ventilator with ventilation rate >12 breaths/min or oxygen supply > 25%, or use high frequency ventilator (HFV)

at IP administration

1. premature infant within postnatal 5 to 14 days of age

2. No improvement in ventilator setting 24 hours prior to administration of IP

Exclusion Criteria:

1. subject with cyanotic congenital heart disease or non-cyanotic congenital heart disease that can cause heart failure

2. subject with pulmonary hypoplasia, congenital diaphragmatic hernia, or serious lung malformation such as congenital cystic lung disease

3. subject with chromosome disorder with serious malformation (i.e. Edward syndrome, patau syndrome, Down syndrome, etc.), severe congenital malformation (i.e. hydrocephalus, encephalocele, etc.), or severe congenital infection (i.e., herpes, toxoplasmosis, rubella, syphilis, AIDS, etc.)

4. subject with serious sepsis as active infection or shock due to sepsis

5. subject with grade 3 or 4 of bilateral intraventricular hemorrhage

6. at screening, subject with active pulmonary hemorrhage or active air leak syndrome

7. subject who underwent/will undergo surgery within 72 hours before/after investigational product (IP) administration

8. subject who is expected to be treated with surfactant within 24 hours prior to IP administration

9. subject who is expected to be allergic to gentamicin (Birth mother's allergy for gentamicin will be confirmed).

10. subject who have previously participated in other clinical trials

11. subject who is considered ineligible by investigator due to other medical reasons

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Severe Bronchopulmonary Dysplasia

Intervention

Biological:
• PNEUMOSTEM
human umbilical cord blood-derived mesenchymal stem cells

Other:
• Placebo
normal saline

Locations

Country	Name	City	State
Korea, Republic of	Asan medical Center	Seoul
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Medipost Co Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of subjects who have severe BPD or are dead	Percentage of subjects who have severe BPD or are dead	36 weeks postmenstrual age (PMA)
Secondary	Percentage of subjects who have moderate/severe BPD or are dead	Percentage of subjects who have moderate/severe BPD or are dead	36 weeks PMA
Secondary	Percentage of subjects by severity of BPD	Percentage of subjects by severity of BPD	prenatal 28 days/36 weeks PMA
Secondary	Percentage of subjects in death due to lung disease	Percentage of subjects in death due to lung disease	prenatal 28 days/36 weeks PMA and study end timepoint
Secondary	intubation duration	intubation duration	up to 24 weeks
Secondary	ventilation duration	ventilation duration	up to 24 weeks
Secondary	continuous positive airway pressure (CPAP) treatment duration	continuous positive airway pressure (CPAP) treatment duration	up to 24 weeks
Secondary	treatment duration with supplemental oxygen	treatment duration with supplemental oxygen	up to 24 weeks
Secondary	% of subjects treated with steroid for weaning ventilator	% of subjects treated with steroid for weaning ventilator	up to 24 weeks
Secondary	Retinopathy of prematurity (ROP) with stage III or higher	number of subjects with ROP with stage III or higher	up to 24 weeks
Secondary	number of subjects with retinopathy of prematurity that needs bevacizumab or laser therapy	number of subjects with retinopathy of prematurity that needs bevacizumab or laser therapy	up to 24 weeks
Secondary	z-score	percentile for body weight, height, and head circumference	up to 24 weeks (visit 10)
Secondary	days in hospitalization	days in hospitalization	up to 24 weeks
Secondary	changes in tracheal suction fluid examination	changes in tracheal suction fluid examination	from screening to 7 days after IP administration (visit 5)