<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02999373</url>
  </required_header>
  <id_info>
    <org_study_id>Guangdong M And C</org_study_id>
    <nct_id>NCT02999373</nct_id>
  </id_info>
  <brief_title>Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates</brief_title>
  <official_title>Autologous Cord Blood Mononuclear Cells for Bronchopulmonary Dysplasia in Very Preterm Neonates</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Women and Children Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Women and Children Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale: Pre-clinical animal studies provide robust evidence regarding the beneficial&#xD;
      effect of cord blood-derived mononuclear cells (MNCs) for experimental bronchopulmonary&#xD;
      dysplasia (BPD).&#xD;
&#xD;
      This single-center, non-randomized, controlled, blinded trial assessed the effect of a single&#xD;
      intravenous infusion of autologous cord blood MNCs (ACBMNCs) in preventing BPD in very&#xD;
      preterm neonates, a high-risk population.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">January 1, 2020</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>bronchopulmonary dysplasia at 36 weeks of postmenstrual age or the discharge home</measure>
    <time_frame>36 weeks of postmenstrual age or the discharge</time_frame>
    <description>bronchopulmonary dysplasia rate</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of patients with severe BPD in survivors</measure>
    <time_frame>36 weeks of postmenstrual age or the discharge</time_frame>
    <description>severe BPD in survivors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients died before discharge from hospital</measure>
    <time_frame>before discharge from hospital</time_frame>
    <description>mortality before discharge from hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>the duration of mechanical ventilation</measure>
    <time_frame>before discharge from hospital</time_frame>
    <description>Other outcomes</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Bronchopulmonary Dysplasia</condition>
  <condition>Premature</condition>
  <condition>Neonatal Death</condition>
  <arm_group>
    <arm_group_label>Autologous cord blood mononuclear cells</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Autologous Umbilical Cord Blood Mononuclear Cells Therapy 24 hours after birth ,dose is 50 million cells/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Autologous Umbilical Cord Blood Mononuclear Cells Therapy</intervention_name>
    <description>Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of infection</description>
    <arm_group_label>Autologous cord blood mononuclear cells</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria: (1) born at the study hospital; (2) singleton birth; (3) GA &lt;32 weeks;&#xD;
        (4) free of severe congenital anomalies or genetic syndromes; (5) without clinical&#xD;
        chorioamnionitis; (6) the mother was negative for hepatitis B (HBsAg and/or HBeAg),&#xD;
        hepatitis C (anti-HCV), syphilis, HIV (anti-HIV-1 and -2), and IgM against cytomegalovirus,&#xD;
        rubella, toxoplasma, and herpes simplex viruses; (7) consent was obtained from the parents&#xD;
        or guardians; and (8) after processing, UCB cells were available.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>0 Weeks</minimum_age>
    <maximum_age>32 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jie Yang, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangdong Women and Children Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Jie Yang</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>511442</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>23673863</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>26051681</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22225756</PMID>
  </reference>
  <reference>
    <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</citation>
  </reference>
  <reference>
    <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.</citation>
    <PMID>24046202</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>25913273</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>23911205</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>19482760</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>24877996</PMID>
  </reference>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>December 3, 2016</study_first_submitted>
  <study_first_submitted_qc>December 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>October 26, 2021</last_update_submitted>
  <last_update_submitted_qc>October 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guangdong Women and Children Hospital</investigator_affiliation>
    <investigator_full_name>yang jie</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>prevention</keyword>
  <keyword>Bronchopulmonary Dysplasia</keyword>
  <keyword>preterm</keyword>
  <keyword>cord blood mononuclear cells</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
    <mesh_term>Perinatal Death</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>November 15, 2021</submitted>
    <submission_canceled>November 18, 2021</submission_canceled>
    <submitted>November 18, 2021</submitted>
    <returned>January 27, 2022</returned>
    <submitted>July 23, 2022</submitted>
    <submission_canceled>August 4, 2022</submission_canceled>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02999373
org study id: Guangdong M And C
nct id: NCT02999373
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: bronchopulmonary dysplasia at 36 weeks of postmenstrual age or the discharge home
time frame: 36 weeks of postmenstrual age or the discharge
description: bronchopulmonary dysplasia rate
measure: number of patients with severe BPD in survivors
time frame: 36 weeks of postmenstrual age or the discharge
description: severe BPD in survivors
measure: number of patients died before discharge from hospital
time frame: before discharge from hospital
description: mortality before discharge from hospital
measure: the duration of mechanical ventilation
time frame: before discharge from hospital
description: Other outcomes
arm group label: Autologous cord blood mononuclear cells
arm group type: Experimental
description: Autologous Umbilical Cord Blood Mononuclear Cells Therapy 24 hours after birth ,dose is 50 million cells/kg
arm group label: control
arm group type: No Intervention
intervention type: Other
intervention name: Autologous Umbilical Cord Blood Mononuclear Cells Therapy
description: Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of infection
arm group label: Autologous cord blood mononuclear cells
criteria: 
gender: All
minimum age: 0 Weeks
maximum age: 32 Weeks
healthy volunteers: No
last name: Jie Yang, PHD
role: Principal Investigator
affiliation: Guangdong Women and Children Hospital
facility: 
country: China
citation: 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: 23673863
citation: 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: 26051681
citation: 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: 22225756
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
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.
PMID: 24046202
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.
PMID: 25913273
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.
PMID: 23911205
citation: 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: 19482760
citation: 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: 24877996
responsible party type: Principal Investigator
investigator affiliation: Guangdong Women and Children Hospital
investigator full name: yang jie
investigator title: Professor
mesh term: Bronchopulmonary Dysplasia
mesh term: Perinatal Death
mesh term: Hyperplasia
sharing ipd: No
submitted: November 15, 2021
submission canceled: November 18, 2021
submitted: November 18, 2021
returned: January 27, 2022
submitted: July 23, 2022
submission canceled: August 4, 2022