Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)

Bronchopulmonary Dysplasia Clinical Trial

— IUMTB  

Official title:

Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03645525
• Other study ID #: EKYYIUMTB
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: December 1, 2019
• Est. completion date: April 1, 2023

Study information

• Verified date: December 2023
• Source: Children's Hospital of Fudan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2023
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Weeks to 3 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia
• Hyperplasia

Intervention

Drug:
• Human Umbilical Cord-derived Mesenchymal stem cell
The Human Umbilical Cord-derived Mesenchymal stem cells suspension (2×10^7/kg per KG of the infant 's weight ) will be instilled once through a catheter into the infant' s endotracheal tube
• placebo
saline

Locations

Country	Name	City	State
China	Children's Hospital of Fudan University	Shanghai	Shanghai
China	Obstetrics and Gynecology Hospital of Fudan University	Shanghai	Shanghai
China	Shanghai First Maternity and Infant Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oxygen requirement 3 days after transplantation	Temporal profiles of the fraction of inspiration oxygen 3 days after transplantation, the tolerable required oxygen ,which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in %	3 days
Secondary	Oxygen requirement 7 days after transplantation	Temporal profiles of the fraction of inspiration oxygen 7 days after transplantation, the tolerable required oxygen ,which is the minimum fraction of inspiration oxygen in which the participants has a stable SpO2 (90%-95%), measured in %	7 days
Secondary	Duration of ventilator dependence	The duration from transplantation to weaning from ventilator	up to 36 weeks PMA
Secondary	Incidence of severe BPD	percentage of participants with severe BPD ,diagnosed at 36 weeks PMA	up to 36 weeks PMA
Secondary	Survival rate	Percentage of participants who survived up to 36 weeks PMA	up to 36 weeks PMA
Secondary	Temperature	Temporal profiles of temperature	3 days
Secondary	Heart rate	Temporal profiles of heart rate	3 days
Secondary	Respiratory rate	Temporal profiles of respiratory rate	3 days
Secondary	Duration of CPAP treatment	Duration of CPAP treatment	up to 36 weeks PMA
Secondary	Percentage of participants treated with steroids for weaning from ventilator	Percentage of participants treated with steroids for weaning from ventilator	up to 36 weeks PMA
Secondary	Growth velocity (Z-score)	percentile for body weight, height, and head circumference	up to 36 weeks PMA
Secondary	bronohoalveolar lavage (BAL) cytokine level	BAL were collected 7 days after transplantation for cytokine (IL-6,IL-8,TNF-a,TGF-ß,VEGF,HGF) level examination, measured in pg/ml	7 days
Secondary	The severity of BPD in X-ray patterns	A chest X-ray was performed in participants before and after transplantation. The severity of BPD (mild,moderate,severe) was assessed by a single radiographic doctor who is blind about randomization	7 days