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Effect of Autologous Cord Blood Mononuclear Cells for Treatment of Bronchopulmonary Dysplasia in Extremely Preterm Neonates

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ClinicalTrials.gov Identifier: NCT05071638
Recruitment Status : Not yet recruiting
First Posted : October 8, 2021
Last Update Posted : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
yang jie, Guangdong Women and Children Hospital

Brief Summary:
This is a non-randomized, case-controlled trial that evaluates the efficacy of autologous cord blood mononuclear cells(ACBMNC) infusion as a Treatment for BPD. The results of this trial will provide valuable clinical evidence for recommendations on the treatment of BPD in extremely preterm infants. Informed consent before birth is signed. In this prospective clinical trial, preterm neonates less than 28 weeks who previously stored ACBMNC and then suffer BPD will be assigned to be ACBMNC infusion group, while those who do not previously stored ACBMNC or then refuse ACBMNC infusion and suffer BPD will be assigned to be control group. In the ACBMNC infusion group, when BPD occurred, the pre-stored ACBMNC will be removed and rewarmed, and then ACBMNC(5×107 cells /kg) will be intravenously injected within 24 hours. The control group receives standardized treatment without special treatment. The total number of participants is 76 and the same in both groups. The primary outcome is the rate of mortality or ratio of severe BPD at 36 weeks of postmenstrual age or discharge home. The secondary outcomes will include other common preterm complication rate and the number of hospitalizations due to pneumonia within 1 year of postmenstrual age.

Condition or disease Intervention/treatment Phase
BPD Biological: autologous cord blood mononuclear cells Phase 3

Detailed Description:

Study design and settings:

This is a non-randomized, case-controlled trial that evaluates the efficacy of autologous cord blood mononuclear cells(ACBMNC) infusion as a Treatment for BPD. Informed consent before birth is signed. Preterm infants in the ACBMNC infusion group will have their umbilical cord blood collected after birth. Umbilical cord blood was collected into a collection bag after delivery and labeled. The collection bag was placed in a 4° refrigerator for refrigeration and sent to the Guangdong Province umbilical cord blood Bank. ACBMNC will be separated and preserved with liquid nitrogen. The total content of umbilical cord blood cells, the number of mononuclear cells per ml and the volume before and after separation were provided immediately for the later calculation of the total volume of infusion. In this prospective clinical trial, preterm neonates less than 28 weeks who previously stored ACBMNC and then suffer BPD will be assigned to be ACBMNC infusion group, while those who do not previously stored ACBMNC or then refuse ACBMNC infusion and suffer BPD will be assigned to be control group. In the ACBMNC infusion group, when BPD occurred, the pre-stored ACBMNC will be removed and rewarmed, and then ACBMNC(5×107 cells /kg) will be intravenously injected within 24 hours. The control group receives standardized treatment without special treatment. The total number of participants is 76 and the same in both groups. The primary outcome is the rate of mortality or ratio of severe BPD at 36 weeks of postmenstrual age or discharge home. The secondary outcomes will include other common preterm complication rate and the number of hospitalizations due to pneumonia within 1 year of postmenstrual age.

Trial treatment methods:

Informed consent before birth will be signed by the parents. All premature infants included in the study received standardized treatment after admission to the NICU. In the ACBMNC infusion group, when BPD occurred, the pre-stored ACBMNC will be removed and rewarmed, and then ACBMNC(5×107 cells /kg) will be intravenously injected within 24 hours. The control group receives standardized treatment without special treatment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a non-randomized, case-controlled trial that evaluates the efficacy of autologous cord blood mononuclear cells(ACBMNC) infusion as a Treatment for BPD.In this prospective clinical trial, preterm neonates less than 28 weeks who previously stored ACBMNC and then suffer BPD will be assigned to be ACBMNC infusion group, while those who do not previously stored ACBMNC or then refuse ACBMNC infusion and suffer BPD will be assigned to be control group. In the ACBMNC infusion group, when BPD occurred, the pre-stored ACBMNC will be removed and rewarmed, and then ACBMNC(5×107 cells /kg) will be intravenously injected within 24 hours. The control group receives standardized treatment without special treatment. The total number of participants is 76 and the same in both groups.
Masking: Double (Care Provider, Investigator)
Masking Description: A hospital ethics committee reviewed the study data during the trials. None of them were involved in the study or aware of the treatment-group assignments of the infants. Nurses and physicians staff conducted the infusion are not aware of the treatment assignment, and these individuals had no contact with the staff who collected and analyzed the patients data. The parents are aware of the assignment.
Primary Purpose: Treatment
Official Title: Effect of Autologous Cord Blood Mononuclear Cells for Treatment of Bronchopulmonary Dysplasia in Extremely Preterm Neonates: a Non-Randomized Case-Control Trial Study
Estimated Study Start Date : October 1, 2021
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : September 30, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ACBMNC infusion group
Those assigned to the ACBMNC group will receive intravenous autologous cord blood mononuclear cells infusion. Cell dose for all patients was targeted at 5×107 cells per kilogram.
Biological: autologous cord blood mononuclear cells
preterm neonates less than 28 weeks who suffer BPD and also stored cord blood are assigned to receive intravenous autologous cord blood mononuclear cells infusion (5×107cells/kg).

No Intervention: control group
The control group received standardized treatment without special treatment.



Primary Outcome Measures :
  1. Rate of mortality or ratio of severe BPD [ Time Frame: 36 weeks of postmenstrual age or discharge home whichever comes first. ]
    Rate of mortality or ratio of severe BPD at discharge or corrected gestational age at 36 weeks


Secondary Outcome Measures :
  1. Incidence of other preterm complications [ Time Frame: 36 weeks of postmenstrual age or the discharge home whichever comes first. ]
    Incidence of other preterm complications including intraventricular hemorrhage (IVH), periventricular leukomalacia(PVL), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), ventilation-associated pneumonia (VAP) and late onset sepsis (LOS)

  2. The number of hospitalizations [ Time Frame: 1 or 2 year of postmenstrual age ]

    To compare the number of hospitalizations due to pneumonia, wheezing, asthma, nighttime cough, need for oxygen therapy, height, weight, nervous system development within 1 or 2 year of postmenstrual age.

    Long-term outcome.




Information from the National Library of Medicine

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

Inclusion Criteria:

  • 1.born at study hospital;
  • 2. singleton birth;
  • 3. less than 28 weeks GA
  • 4.Signed informed consent obtained;
  • 5. Umbilical cord blood collection and testing qualified; 6.Diagnosed with BPD

Exclusion Criteria:

  • 1. with severe congenital abnormalities;
  • 2.with maternal clinical chorioamnionitis
  • 3. the mother was positive for hepatitis B (HBsAg and/or HBeAg) or C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) or IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus.

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): NCT05071638


Contacts
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Contact: Zhuxiao Ren, MD +8613538984634 renzhx1990@163.com

Locations
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China, Guangdong
Ren Xuejun
Dongguan, Guangdong, China
Jie Yang
Guangzhou, Guangdong, China, 511400
Sponsors and Collaborators
Guangdong Women and Children Hospital
Investigators
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Study Chair: Jie Yang, PhD Guangdong Women and Children Hospital
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Responsible Party: yang jie, Professor, Guangdong Women and Children Hospital
ClinicalTrials.gov Identifier: NCT05071638    
Other Study ID Numbers: Guangdong MCH
First Posted: October 8, 2021    Key Record Dates
Last Update Posted: October 8, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Analytic Code
Time Frame: all time
Access Criteria: all

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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 yang jie, Guangdong Women and Children Hospital:
Autologous cord blood mononuclear cells
bronchopulmonary dysplasia
extremely preterm neonates
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