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

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ClinicalTrials.gov Identifier: NCT03645525
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : October 25, 2022
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Fudan University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bronchopulmonary Dysplasia Drug: Human Umbilical Cord-derived Mesenchymal stem cell Drug: placebo Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
Actual Study Start Date : December 1, 2019
Estimated Primary Completion Date : October 30, 2022
Estimated Study Completion Date : April 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Oxygen requirement 3 days after transplantation [ Time Frame: 3 days ]
    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 :
  1. Oxygen requirement 7 days after transplantation [ Time Frame: 7 days ]
    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 %

  2. Duration of ventilator dependence [ Time Frame: up to 36 weeks PMA ]
    The duration from transplantation to weaning from ventilator

  3. Incidence of severe BPD [ Time Frame: up to 36 weeks PMA ]
    percentage of participants with severe BPD ,diagnosed at 36 weeks PMA

  4. Survival rate [ Time Frame: up to 36 weeks PMA ]
    Percentage of participants who survived up to 36 weeks PMA

  5. Temperature [ Time Frame: 3 days ]
    Temporal profiles of temperature

  6. Heart rate [ Time Frame: 3 days ]
    Temporal profiles of heart rate

  7. Respiratory rate [ Time Frame: 3 days ]
    Temporal profiles of respiratory rate

  8. Duration of CPAP treatment [ Time Frame: up to 36 weeks PMA ]
    Duration of CPAP treatment

  9. Percentage of participants treated with steroids for weaning from ventilator [ Time Frame: up to 36 weeks PMA ]
    Percentage of participants treated with steroids for weaning from ventilator

  10. Growth velocity (Z-score) [ Time Frame: up to 36 weeks PMA ]
    percentile for body weight, height, and head circumference

  11. bronohoalveolar lavage (BAL) cytokine level [ Time Frame: 7 days ]
    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

  12. The severity of BPD in X-ray patterns [ Time Frame: 7 days ]
    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


Eligibility Criteria
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Ages Eligible for Study:   2 Weeks to 3 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645525


Contacts
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Contact: Chen Chao, PhD,MD 86-13681709999 chen6010@163.com

Locations
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China, Shanghai
Obstetrics and Gynecology Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 200011
Contact: Lu Chengqiu         
Children's Hospital of Fudan University Recruiting
Shanghai, Shanghai, China, 201102
Contact: Chao Chen, PhD, MD    13681709999      
Principal Investigator: Chengqiu Lu, MD         
Principal Investigator: Jie Lin, MD         
Shanghai First Maternity and Infant Hospital Recruiting
Shanghai, Shanghai, China, 201204
Contact: Jiangqin Liu         
Sponsors and Collaborators
Children's Hospital of Fudan University
Investigators
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Study Director: Chen Chao, PhD,MD Chiledren's Hospital of Fudan University
More Information
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Responsible Party: Children's Hospital of Fudan University
ClinicalTrials.gov Identifier: NCT03645525    
Other Study ID Numbers: EKYYIUMTB
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: October 25, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital of Fudan University:
Bronchopulmonary Dysplasia
Mesenchymal stem cell
Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Hyperplasia
Pathologic Processes
Ventilator-Induced Lung Injury
Lung Injury
 Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases