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The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells

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ClinicalTrials.gov Identifier: NCT03683953
Recruitment Status : Not yet recruiting
First Posted : September 25, 2018
Last Update Posted : September 25, 2018
Sponsor:
Information provided by (Responsible Party):
yangjie, Guangdong Women and Children Hospital

Brief Summary:
To study the effect and saftey of intratracheal instillation of mesenchymal stem cells for treatment BPD

Condition or disease Intervention/treatment Phase
Safety Issues Effect of Drugs Other: mesenchymal stem cells therapy Drug: 0.9% sodium chloride Phase 1

Detailed Description:

This is a Phase 1 clinical trial that constitues two points cohorts with 100 participants per cohort who will receive instillation dose of mesenchymal stem cells-25 million cells/kg,with ventilation after 14 days.And the placebol will be 0.9% sodium choride. The investigator will proceed the groups during the same period.

  1. Deographic Data and Baseline charateristics of the studied groups were collected:

    Gestational age (weeks) Birth weight (g) gender Cesarean section delivery Antenatal steroids Prolonged rupture of membrane Multiple pregnancies APGAR score at 5 minutes

  2. mesenchymal stem cels dose is 25 million cells/kg
  3. Assessment the incidence of BPD after instillation of Mesenchymal stem cells
  4. the adverse after instillation of Mesenchymal stem cells

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Treatment of Bronchopulmonary Dysplasia by Intratracheal Instillation of Mesenchymal Stem Cells
Estimated Study Start Date : September 29, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
0.9% sodium chloride intratracheal instillate on 14 days after birth
Drug: 0.9% sodium chloride
0.9% sodium chloride in control group

Experimental: mesenchymal stem cells
mesenchymal stem cells intratracheal instillate on 14 days after birth ,dose is 25 million cells/kg
Other: mesenchymal stem cells therapy
mesenchymal stem cells treatement of BPD for safety and effect evaluation0.9% sodium chloride incontrol group




Primary Outcome Measures :
  1. number of patients with BPD after instillation mesenchymal stem cells [ Time Frame: up to 28 days after birth ]
    incidence of BPD



Information from the National Library of Medicine

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Ages Eligible for Study:   28 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

twenty-eight weeks to thirty-seven weeks prematures who need ventilaton for 14 days after birth, and the oxygen concentration is more than 30%

Exclusion Criteria:

Preterm infants with major congenital malformations, chromosomal anomalies, inborn errors of metabolism and clinical or laboratory evidence of a congenital infection


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): NCT03683953


Contacts
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Contact: Zhuxiao Ren, MD +8613538984634 ext +86 renzhx1990@163.com
Contact: Jie Yang, PHD 39151777 ext 020 jieyang0830@163.com

Sponsors and Collaborators
Guangdong Women and Children Hospital
Investigators
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Principal Investigator: Jie Yang, PHD Guangzhou, Guangdong,China,511442

Publications of Results:
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Responsible Party: yangjie, Professor, Guangdong Women and Children Hospital
ClinicalTrials.gov Identifier: NCT03683953     History of Changes
Other Study ID Numbers: Guangdong W CH
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: July 2018
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 yangjie, Guangdong Women and Children Hospital:
mesenchymal stem cells
safety
effect
BPD

Additional relevant MeSH terms:
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Bronchopulmonary Dysplasia
Ventilator-Induced Lung Injury
Lung Injury
Lung Diseases
Respiratory Tract Diseases
Infant, Premature, Diseases
Infant, Newborn, Diseases