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

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.

Study Overview

• Status: Withdrawn
• Conditions: Bronchopulmonary Dysplasia
• Intervention / Treatment: Drug: placebo; Drug: Human Umbilical Cord-derived Mesenchymal stem cell

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 201102
      • Children's Hospital of Fudan University
    • Shanghai, Shanghai, China, 200011
      • Obstetrics and Gynecology Hospital of Fudan University
    • Shanghai, Shanghai, China, 201204
      • Shanghai First Maternity and Infant Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 weeks to 3 weeks (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mesenchymal stem cell; Human Umbilical Cord-derived Mesenchymal stem cell in the saline	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 Comparator: placebo; saline without mesenchymal stem cell	Drug: placebo; saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Duration of ventilator dependence	The duration from transplantation to weaning from ventilator	up to 36 weeks PMA
Incidence of severe BPD	percentage of participants with severe BPD ,diagnosed at 36 weeks PMA	up to 36 weeks PMA
Survival rate	Percentage of participants who survived up to 36 weeks PMA	up to 36 weeks PMA
Temperature	Temporal profiles of temperature	3 days
Heart rate	Temporal profiles of heart rate	3 days
Respiratory rate	Temporal profiles of respiratory rate	3 days
Duration of CPAP treatment	Duration of CPAP treatment	up to 36 weeks PMA
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
Growth velocity (Z-score)	percentile for body weight, height, and head circumference	up to 36 weeks PMA
bronohoalveolar lavage (BAL) cytokine level	BAL were collected 7 days after transplantation for cytokine (IL-6，IL-8，TNF-α，TGF-β,VEGF,HGF) level examination, measured in pg/ml	7 days
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

Collaborators and Investigators

• Sponsor: Children's Hospital of Fudan University
• Investigators: Study Director: Chen Chao, PhD,MD, Chiledren's Hospital of Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2019
• Primary Completion (Estimated): October 30, 2022
• Study Completion (Estimated): April 1, 2023

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 23, 2018
• First Posted (Actual): August 24, 2018

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Mesenchymal stem cell; Bronchopulmonary Dysplasia
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Hyperplasia; Bronchopulmonary Dysplasia
• Other Study ID Numbers: EKYYIUMTB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No