Clinical trial NCT03645525: Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
Official title: Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Bronchopulmonary Dysplasia
Keywords: Bronchopulmonary Dysplasia
Mesenchymal stem cell
Lead sponsor: Children's Hospital of Fudan University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 0
Sex: ALL
Minimum age (years): 2
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD).A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.

Detailed description: Brochopulmonary dysplasia is a severe chronic lung disease in extremely preterm infants. The morbidity of BPD is increasing in CHINA. The preventive and therapy methods of BPD are still lacking.

Umbilical Cord-derived Mesenchymal stem cell has been proven effective in the experimental bronchopulmonary dysplasia (BPD). A multi-center study was designed to evaluate the safety and efficacy of the cellular therapy in extremely preterm infants at high risk for BPD.

Eligibility criteria: Inclusion Criteria:

* Extremely preterm infants who remain on mechanic ventilator after 2 weeks of postnatal age
* Extremely preterm infants with a X-ray sign of BPD after 2 weeks of postnatal age

Exclusion Criteria:

* Patients with severe congenital diseases
* Patients with IVH more than 3 grade
* Patients with severe sepsis
* Patients with active pulmonary hemorrhage

Primary outcomes:
measure: Oxygen requirement 3 days after transplantation
timeFrame: 3 days
Secondary outcomes:
measure: Oxygen requirement 7 days after transplantation
timeFrame: 7 days
measure: Duration of ventilator dependence
timeFrame: up to 36 weeks PMA
measure: Incidence of severe BPD
timeFrame: up to 36 weeks PMA
measure: Survival rate
timeFrame: up to 36 weeks PMA
measure: Temperature
timeFrame: 3 days
measure: Heart rate
timeFrame: 3 days
measure: Respiratory rate
timeFrame: 3 days
measure: Duration of CPAP treatment
timeFrame: up to 36 weeks PMA
measure: Percentage of participants treated with steroids for weaning from ventilator
timeFrame: up to 36 weeks PMA
measure: Growth velocity (Z-score)
timeFrame: up to 36 weeks PMA
measure: bronohoalveolar lavage (BAL) cytokine level
timeFrame: 7 days
measure: The severity of BPD in X-ray patterns
timeFrame: 7 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Obstetrics and Gynecology Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Children's Hospital of Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Shanghai First Maternity and Infant Hospital
state: Shanghai
Study officials:
affiliation: Chiledren's Hospital of Fudan University
name: Chen Chao, PhD,MD
role: STUDY_DIRECTOR
References: