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Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia

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ClinicalTrials.gov Identifier: NCT03352310
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : June 7, 2018
Sponsor:
Collaborators:
Chinese University of Hong Kong
China Spinal Cord Injury Network
Information provided by (Responsible Party):
Mononuclear Therapeutics Ltd.

Tracking Information
First Submitted Date  ICMJE November 15, 2017
First Posted Date  ICMJE November 24, 2017
Last Update Posted Date June 7, 2018
Actual Study Start Date  ICMJE April 16, 2018
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
  • HIE: Mortality [ Time Frame: 6 months ]
    Mortality Rate of the HIE Subjects
  • Anemia: Change from Baseline Hematocrit [ Time Frame: 48 hours, 1 week, 3 months, 6 months ]
    Change from Baseline Hematocrit of the Anemia Subjects
Original Primary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • HIE: Mortality [ Time Frame: 6 months ]
    Mortality Rate of the HIE Subjects
  • Anemia: Change from Baseline Hematocrit [ Time Frame: 48 hours, 1 week, 1 month, 3 months, 6 months ]
    Change from Baseline Hematocrit of the Anemia Subjects
Change History Complete list of historical versions of study NCT03352310 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2018)
  • HIE: HINE [ Time Frame: 6 months, 1 year and 2 years ]
    Hammersmith Infant Neurological Examination (HINE) of the HIE Subjects
  • HIE: HNNE [ Time Frame: -1 day, 3 months (before discharge) ]
    Hammersmith Neonatal Neurological Examination (HNNE) of the HIE Subjects
  • HIE: GMDS [ Time Frame: 6 months, 1 year and 2 years ]
    Griffiths Mental Development Scale (GMDS) of the HIE Subjects
  • HIE: CBCL [ Time Frame: 2 years ]
    Child Behavior Checklist for Attention Deficit of the HIE Subjects
  • HIE: Q-CHAT [ Time Frame: 2 years ]
    Quantitative Checklist for Autism in Toddlers of the HIE Subjects
  • Anemia: hemoglobin [ Time Frame: 48 hours, 1 week, 3 months and 6 months ]
    Change from Baseline hemoglobin of the Anemia Subjects
  • Anemia: Oxygenation level [ Time Frame: 48 hours, 1 week ]
    Change from Baseline SpO2 of the Anemia Subjects
  • Anemia: Oxidative Stress Level [ Time Frame: 48 hours, 1 week, 3 months, and 6 months ]
    Change of Baseline Isoprostane of the Anemia Subjects
  • Anemia: Requirements of Packed Cell Transfusion [ Time Frame: 6 months ]
    Frequency of Requirements of Packed Cell Transfusion by the Anemia Subjects
Original Secondary Outcome Measures  ICMJE
 (submitted: November 21, 2017)
  • HIE: HINE [ Time Frame: 0 day, 6 months ]
    Hammersmith Infant Neurological Examination (HINE) of the HIE Subjects
  • HIE: GMDS [ Time Frame: 6 months, 1 year and 2 years ]
    Griffiths Mental Development Scale (GMDS) of the HIE Subjects
  • HIE: CBCL [ Time Frame: 6 months, 1 year and 2 years ]
    Child Behavior Checklist for Attention Deficit of the HIE Subjects
  • HIE: Q-CHAT [ Time Frame: 6 months, 1 year and 2 years ]
    Quantitative Checklist for Autism in Toddlers of the HIE Subjects
  • Anemia: hemoglobin [ Time Frame: 48 hours, 1 week, 1 month, 3 months and 6 months ]
    Change from Baseline hemoglobin of the Anemia Subjects
  • Anemia: Oxygenation level [ Time Frame: 48 hours, 1 week ]
    Change from Baseline SpO2 of the Anemia Subjects
  • Anemia: Oxidative Stress Level [ Time Frame: 48 hours, 1 week, 1 month, 3 months, and 6 months ]
    Change of Baseline Isoprostane of the Anemia Subjects
  • Anemia: Requirements of Packed Cell Transfusion [ Time Frame: 6 months ]
    Frequency of Requirements of Packed Cell Transfusion by the Anemia Subjects
Current Other Pre-specified Outcome Measures
 (submitted: November 21, 2017)
Incidence of Adverse Event [ Time Frame: 2 years ]
Safety outcomes are Incidence of Adverse Events
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia
Official Title  ICMJE Umbilical Cord Blood Mononuclear Cell Bank in Hong Kong and Treatment of Neonatal Cerebral Ischemia and Anemia - Part IV Clinical Trial
Brief Summary

The study is to investigate the feasibility and safety of autologous umbilical cord blood transfusion to treat the newborn infants with presence of clinical indications of neonatal hypoxic-ischemia encephalopathy (HIE) and anemia. Umbilical cord blood (UCB) is collected following labor and is transfused intravenously within 48 hours after the birth. Newborn infant without UCB available recieves the standard care will be enrolled as control group.

Following the autologous UCB transfusion in the study group or standard care in the control group, HIE subjects will be followed for 2 years for survival and neurodevelopmental outcomes and anemia subjects will be followed for 6 months to assess the survival and change of hematocrit and hemoglobin levels.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Study Group - autologous umbilcial cord blood transfusion

Control Group - standard care

Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hypoxic-Ischemic Encephalopathy
  • Hypoxia Neonatal
  • Cerebral Ischemia of Newborn
  • Anemia, Neonatal
Intervention  ICMJE
  • Biological: autologous umbilical cord blood (UCB)
    autologous UCB transfusion to the newborn infants presence of HIE and/or anemia within 48 hours after the birth
  • Procedure: standard care
    standard care procedure to the newborn infants presence of HIE and/or anemia
Study Arms  ICMJE
  • Experimental: Study Group
    autologous UCB transfusion
    Intervention: Biological: autologous umbilical cord blood (UCB)
  • Control Group
    standard care
    Intervention: Procedure: standard care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 21, 2017)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 30, 2020
Estimated Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • evidence of asphyxiation, defined by 5-minute Apgar score ≤ 5;
  • evidence of HIE, defined by UCB pH <7.15 or base excess ≤ 10mM;
  • subjects with HIE confirmed by clinical features and initial investigations;
  • subjects with evidence of anemia, defined by hematocrit < 40% or hemoglobin ≤ 13g/dL within the first 96 hours of life;
  • obtain the informed consent from parents

Exclusion Criteria:

  • congestive cardiac failure;
  • microcephaly, anencephaly, encephalocele, or other abnormality
  • conjoint twins;
  • chromosomal disorders
  • fetal alcohol syndrome
  • spinal bifida or other neural tube defects
  • subjects have other neurological deficit conditions
  • polycythemia
  • congenital hematological malignancy
  • investigator decision
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 48 Hours   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Simon Lam, MD +852 35052851 hshslam@cuhk.edu.hk
Contact: Ronald Wang, MD +852 35052810
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03352310
Other Study ID Numbers  ICMJE UCB-HIEA-01
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Mononuclear Therapeutics Ltd.
Study Sponsor  ICMJE Mononuclear Therapeutics Ltd.
Collaborators  ICMJE
  • Chinese University of Hong Kong
  • China Spinal Cord Injury Network
Investigators  ICMJE
Principal Investigator: Simon Lam, MD Chinese University of Hong Kong
PRS Account Mononuclear Therapeutics Ltd.
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP