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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

Tracking Information
First Submitted Date  ICMJE August 16, 2018
First Posted Date  ICMJE August 24, 2018
Last Update Posted Date October 25, 2022
Actual Study Start Date  ICMJE December 1, 2019
Estimated Primary Completion Date October 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2018)		 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 %
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 23, 2018)
  • 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 %
  • Duration of ventilator dependence [ Time Frame: up to 36 weeks PMA ]
    The duration from transplantation to weaning from ventilator
  • Incidence of severe BPD [ Time Frame: up to 36 weeks PMA ]
    percentage of participants with severe BPD ,diagnosed at 36 weeks PMA
  • Survival rate [ Time Frame: up to 36 weeks PMA ]
    Percentage of participants who survived up to 36 weeks PMA
  • Temperature [ Time Frame: 3 days ]
    Temporal profiles of temperature
  • Heart rate [ Time Frame: 3 days ]
    Temporal profiles of heart rate
  • Respiratory rate [ Time Frame: 3 days ]
    Temporal profiles of respiratory rate
  • Duration of CPAP treatment [ Time Frame: up to 36 weeks PMA ]
    Duration of CPAP treatment
  • 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
  • Growth velocity (Z-score) [ Time Frame: up to 36 weeks PMA ]
    percentile for body weight, height, and head circumference
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
Official Title  ICMJE Intratracheal Umbilical Cord-derived Mesenchymal Stem Cell for the Treatment of Bronchopulmonary Dysplasia (BPD)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bronchopulmonary Dysplasia
Intervention  ICMJE
  • 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
  • Drug: placebo
    saline
Study Arms  ICMJE
  • Experimental: Mesenchymal stem cell
    Human Umbilical Cord-derived Mesenchymal stem cell in the saline
    Intervention: Drug: Human Umbilical Cord-derived Mesenchymal stem cell
  • Placebo Comparator: placebo
    saline without mesenchymal stem cell
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2018)		 180
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2023
Estimated Primary Completion Date October 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Weeks to 3 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Chen Chao, PhD,MD 86-13681709999 chen6010@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03645525
Other Study ID Numbers  ICMJE EKYYIUMTB
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party Children's Hospital of Fudan University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Children's Hospital of Fudan University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Chen Chao, PhD,MD Chiledren's Hospital of Fudan University
PRS Account Children's Hospital of Fudan University
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP