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Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates

Primary Purpose

Bronchopulmonary Dysplasia, Premature, Neonatal Death

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Autologous Umbilical Cord Blood Mononuclear Cells Therapy
Sponsored by
Guangdong Women and Children Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Bronchopulmonary Dysplasia focused on measuring prevention, Bronchopulmonary Dysplasia, preterm, cord blood mononuclear cells

Eligibility Criteria

0 Weeks - 32 Weeks (Child)All SexesDoes not accept healthy volunteers
Inclusion Criteria: (1) born at the study hospital; (2) singleton birth; (3) GA <32 weeks; (4) free of severe congenital anomalies or genetic syndromes; (5) without clinical chorioamnionitis; (6) the mother was negative for hepatitis B (HBsAg and/or HBeAg), hepatitis C (anti-HCV), syphilis, HIV (anti-HIV-1 and -2), and IgM against cytomegalovirus, rubella, toxoplasma, and herpes simplex viruses; (7) consent was obtained from the parents or guardians; and (8) after processing, UCB cells were available.

Sites / Locations

  • Jie Yang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Autologous cord blood mononuclear cells

control

Arm Description

Autologous Umbilical Cord Blood Mononuclear Cells Therapy 24 hours after birth ,dose is 50 million cells/kg

Outcomes

Primary Outcome Measures

bronchopulmonary dysplasia at 36 weeks of postmenstrual age or the discharge home
bronchopulmonary dysplasia rate

Secondary Outcome Measures

number of patients with severe BPD in survivors
severe BPD in survivors
number of patients died before discharge from hospital
mortality before discharge from hospital
the duration of mechanical ventilation
Other outcomes

Full Information

First Posted
December 3, 2016
Last Updated
October 26, 2021
Sponsor
Guangdong Women and Children Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02999373
Brief Title
Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates
Official Title
Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
January 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Guangdong Women and Children Hospital

4. Oversight

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

5. Study Description

Brief Summary
Rationale: Pre-clinical animal studies provide robust evidence regarding the beneficial effect of cord blood-derived mononuclear cells (MNCs) for experimental bronchopulmonary dysplasia (BPD). This single-center, non-randomized, controlled, blinded trial assessed the effect of a single intravenous infusion of autologous cord blood MNCs (ACBMNCs) in preventing BPD in very preterm neonates, a high-risk population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchopulmonary Dysplasia, Premature, Neonatal Death
Keywords
prevention, Bronchopulmonary Dysplasia, preterm, cord blood mononuclear cells

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous cord blood mononuclear cells
Arm Type
Experimental
Arm Description
Autologous Umbilical Cord Blood Mononuclear Cells Therapy 24 hours after birth ,dose is 50 million cells/kg
Arm Title
control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Autologous Umbilical Cord Blood Mononuclear Cells Therapy
Intervention Description
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of infection
Primary Outcome Measure Information:
Title
bronchopulmonary dysplasia at 36 weeks of postmenstrual age or the discharge home
Description
bronchopulmonary dysplasia rate
Time Frame
36 weeks of postmenstrual age or the discharge
Secondary Outcome Measure Information:
Title
number of patients with severe BPD in survivors
Description
severe BPD in survivors
Time Frame
36 weeks of postmenstrual age or the discharge
Title
number of patients died before discharge from hospital
Description
mortality before discharge from hospital
Time Frame
before discharge from hospital
Title
the duration of mechanical ventilation
Description
Other outcomes
Time Frame
before discharge from hospital

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: (1) born at the study hospital; (2) singleton birth; (3) GA <32 weeks; (4) free of severe congenital anomalies or genetic syndromes; (5) without clinical chorioamnionitis; (6) the mother was negative for hepatitis B (HBsAg and/or HBeAg), hepatitis C (anti-HCV), syphilis, HIV (anti-HIV-1 and -2), and IgM against cytomegalovirus, rubella, toxoplasma, and herpes simplex viruses; (7) consent was obtained from the parents or guardians; and (8) after processing, UCB cells were available.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jie Yang, PHD
Organizational Affiliation
Guangdong Women and Children Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jie Yang
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
511442
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23673863
Citation
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Results Reference
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Citation
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PubMed Identifier
22225756
Citation
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Results Reference
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Citation
Leung, Kam Tong; Lam, Hugh Simon; Chan, Kathy Yuen Yee, Decreased Frequency of Circulating CD34+Hematopoietic Stem/Progenitor Cells in Preterm Infants with Late-Onset Systemic Bacterial Infection,Blood,2014.124.21
Results Reference
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PubMed Identifier
24046202
Citation
Lam HS, Cheung HM, Poon TC, Wong RP, Leung KT, Li K, Ng PC. Neutrophil CD64 for daily surveillance of systemic infection and necrotizing enterocolitis in preterm infants. Clin Chem. 2013 Dec;59(12):1753-60. doi: 10.1373/clinchem.2013.209536. Epub 2013 Sep 17.
Results Reference
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PubMed Identifier
25913273
Citation
Ho MS, Mei SH, Stewart DJ. The Immunomodulatory and Therapeutic Effects of Mesenchymal Stromal Cells for Acute Lung Injury and Sepsis. J Cell Physiol. 2015 Nov;230(11):2606-17. doi: 10.1002/jcp.25028.
Results Reference
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PubMed Identifier
23911205
Citation
van den Berg JP, van Zwieteren N, Westerbeek EA, Garssen J, van Elburg RM. Neonatal modulation of serum cytokine profiles by a specific mixture of anti-inflammatory neutral and acidic oligosaccharides in preterm infants. Cytokine. 2013 Oct;64(1):188-95. doi: 10.1016/j.cyto.2013.07.002. Epub 2013 Aug 2.
Results Reference
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PubMed Identifier
19482760
Citation
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Results Reference
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Citation
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Results Reference
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Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates

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