NCT02999373

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

December 21, 2016

Completed
1.5 years until next milestone

Study Start

First participant enrolled

July 1, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

1.5 years

First QC Date

December 3, 2016

Last Update Submit

October 26, 2021

Conditions

Bronchopulmonary DysplasiaPrematureNeonatal Death

Keywords

preventionBronchopulmonary Dysplasiapretermcord blood mononuclear cells

Outcome Measures

Primary Outcomes (1)

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

    bronchopulmonary dysplasia rate

    36 weeks of postmenstrual age or the discharge

Secondary Outcomes (3)

  • number of patients with severe BPD in survivors

    36 weeks of postmenstrual age or the discharge

  • number of patients died before discharge from hospital

    before discharge from hospital

  • the duration of mechanical ventilation

    before discharge from hospital

Study Arms (2)

Autologous cord blood mononuclear cells

EXPERIMENTAL

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

Other: Autologous Umbilical Cord Blood Mononuclear Cells Therapy

control

NO INTERVENTION

Interventions

Autologous Umbilical Cord Blood Mononuclear Cells TherapyOTHER

Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of infection

Autologous cord blood mononuclear cells

Eligibility Criteria

Age0 Weeks - 32 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jie Yang

Guangzhou, Guangdong, 511442, China

Location

Related Publications (11)

  • Ballen KK, Gluckman E, Broxmeyer HE. Umbilical cord blood transplantation: the first 25 years and beyond. Blood. 2013 Jul 25;122(4):491-8. doi: 10.1182/blood-2013-02-453175. Epub 2013 May 14.

    PMID: 23673863BACKGROUND

  • Mezey E, Nemeth K. Mesenchymal stem cells and infectious diseases: Smarter than drugs. Immunol Lett. 2015 Dec;168(2):208-14. doi: 10.1016/j.imlet.2015.05.020. Epub 2015 Jun 4.

    PMID: 26051681BACKGROUND

  • Wannemuehler TJ, Manukyan MC, Brewster BD, Rouch J, Poynter JA, Wang Y, Meldrum DR. Advances in mesenchymal stem cell research in sepsis. J Surg Res. 2012 Mar;173(1):113-26. doi: 10.1016/j.jss.2011.09.053. Epub 2011 Oct 24.

    PMID: 22225756BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 24046202BACKGROUND

  • 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.

    PMID: 25913273BACKGROUND

  • 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.

    PMID: 23911205BACKGROUND

  • Lam HS, Wong SP, Liu FY, Wong HL, Fok TF, Ng PC. Attitudes toward neonatal intensive care treatment of preterm infants with a high risk of developing long-term disabilities. Pediatrics. 2009 Jun;123(6):1501-8. doi: 10.1542/peds.2008-2061.

    PMID: 19482760BACKGROUND

  • Strunk T, Inder T, Wang X, Burgner D, Mallard C, Levy O. Infection-induced inflammation and cerebral injury in preterm infants. Lancet Infect Dis. 2014 Aug;14(8):751-762. doi: 10.1016/S1473-3099(14)70710-8. Epub 2014 May 28.

    PMID: 24877996BACKGROUND

  • Ren Z, Yang L, Wang J, Han J, Lin S, Yao Y, Du C, Yang J. Cord blood stem cell-derived Angptl7 ameliorates the severity of bronchopulmonary dysplasia via anti-inflammatory and proangiogenic effects. Mol Med Rep. 2024 Jan;29(1):8. doi: 10.3892/mmr.2023.13131. Epub 2023 Nov 24.

    PMID: 37997800DERIVED

  • Zhuxiao R, Fang X, Wei W, Shumei Y, Jianlan W, Qiuping L, Jingjun P, Chuan N, Yongsheng L, Zhichun F, Jie Y. Prevention for moderate or severe BPD with intravenous infusion of autologous cord blood mononuclear cells in very preterm infants-a prospective non-randomized placebo-controlled trial and two-year follow up outcomes. EClinicalMedicine. 2023 Feb 16;57:101844. doi: 10.1016/j.eclinm.2023.101844. eCollection 2023 Mar.

    PMID: 36864985DERIVED

MeSH Terms

Conditions

Bronchopulmonary DysplasiaPremature BirthPerinatal Death

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jie Yang, PHD

    Guangdong Women and Children Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 3, 2016

First Posted

December 21, 2016

Study Start

July 1, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

November 2, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)