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

Primary Purpose

Bronchopulmonary Dysplasia

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Human Umbilical Cord-derived Mesenchymal stem cell
placebo
Sponsored by
Children's Hospital of Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchopulmonary Dysplasia focused on measuring Bronchopulmonary Dysplasia, Mesenchymal stem cell

Eligibility Criteria

2 Weeks - 3 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Obstetrics and Gynecology Hospital of Fudan UniversityRecruiting
  • Children's Hospital of Fudan UniversityRecruiting
  • Shanghai First Maternity and Infant HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mesenchymal stem cell

placebo

Arm Description

Human Umbilical Cord-derived Mesenchymal stem cell in the saline

saline without mesenchymal stem cell

Outcomes

Primary Outcome Measures

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 %

Secondary Outcome Measures

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 %
Duration of ventilator dependence
The duration from transplantation to weaning from ventilator
Incidence of severe BPD
percentage of participants with severe BPD ,diagnosed at 36 weeks PMA
Survival rate
Percentage of participants who survived up to 36 weeks PMA
Temperature
Temporal profiles of temperature
Heart rate
Temporal profiles of heart rate
Respiratory rate
Temporal profiles of respiratory rate
Duration of CPAP treatment
Duration of CPAP treatment
Percentage of participants treated with steroids for weaning from ventilator
Percentage of participants treated with steroids for weaning from ventilator
Growth velocity (Z-score)
percentile for body weight, height, and head circumference
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
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

Full Information

First Posted
August 16, 2018
Last Updated
October 24, 2022
Sponsor
Children's Hospital of Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT03645525
Brief Title
Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
Acronym
IUMTB
Official Title
Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
October 30, 2022 (Anticipated)
Study Completion Date
April 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia
Keywords
Bronchopulmonary Dysplasia, Mesenchymal stem cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal stem cell
Arm Type
Experimental
Arm Description
Human Umbilical Cord-derived Mesenchymal stem cell in the saline
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
saline without mesenchymal stem cell
Intervention Type
Drug
Intervention Name(s)
Human Umbilical Cord-derived Mesenchymal stem cell
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
saline
Primary Outcome Measure Information:
Title
Oxygen requirement 3 days after transplantation
Description
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 %
Time Frame
3 days
Secondary Outcome Measure Information:
Title
Oxygen requirement 7 days after transplantation
Description
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 %
Time Frame
7 days
Title
Duration of ventilator dependence
Description
The duration from transplantation to weaning from ventilator
Time Frame
up to 36 weeks PMA
Title
Incidence of severe BPD
Description
percentage of participants with severe BPD ,diagnosed at 36 weeks PMA
Time Frame
up to 36 weeks PMA
Title
Survival rate
Description
Percentage of participants who survived up to 36 weeks PMA
Time Frame
up to 36 weeks PMA
Title
Temperature
Description
Temporal profiles of temperature
Time Frame
3 days
Title
Heart rate
Description
Temporal profiles of heart rate
Time Frame
3 days
Title
Respiratory rate
Description
Temporal profiles of respiratory rate
Time Frame
3 days
Title
Duration of CPAP treatment
Description
Duration of CPAP treatment
Time Frame
up to 36 weeks PMA
Title
Percentage of participants treated with steroids for weaning from ventilator
Description
Percentage of participants treated with steroids for weaning from ventilator
Time Frame
up to 36 weeks PMA
Title
Growth velocity (Z-score)
Description
percentile for body weight, height, and head circumference
Time Frame
up to 36 weeks PMA
Title
bronohoalveolar lavage (BAL) cytokine level
Description
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
Time Frame
7 days
Title
The severity of BPD in X-ray patterns
Description
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
Time Frame
7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Weeks
Maximum Age & Unit of Time
3 Weeks
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chen Chao, PhD,MD
Phone
86-13681709999
Email
chen6010@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen Chao, PhD,MD
Organizational Affiliation
Chiledren's Hospital of Fudan University
Official's Role
Study Director
Facility Information:
Facility Name
Obstetrics and Gynecology Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lu Chengqiu
Facility Name
Children's Hospital of Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201102
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chao Chen, PhD, MD
Phone
13681709999
First Name & Middle Initial & Last Name & Degree
Chengqiu Lu, MD
First Name & Middle Initial & Last Name & Degree
Jie Lin, MD
Facility Name
Shanghai First Maternity and Infant Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
201204
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiangqin Liu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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