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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.

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.


Condition or disease Intervention/treatment Phase
Hypoxic-Ischemic Encephalopathy Hypoxia Neonatal Cerebral Ischemia of Newborn Anemia, Neonatal Biological: autologous umbilical cord blood (UCB) Procedure: standard care Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
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
Official Title: Umbilical Cord Blood Mononuclear Cell Bank in Hong Kong and Treatment of Neonatal Cerebral Ischemia and Anemia - Part IV Clinical Trial
Actual Study Start Date : April 16, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : December 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Study Group
autologous UCB transfusion
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

Control Group
standard care
Procedure: standard care
standard care procedure to the newborn infants presence of HIE and/or anemia




Primary Outcome Measures :
  1. HIE: Mortality [ Time Frame: 6 months ]
    Mortality Rate of the HIE Subjects

  2. Anemia: Change from Baseline Hematocrit [ Time Frame: 48 hours, 1 week, 3 months, 6 months ]
    Change from Baseline Hematocrit of the Anemia Subjects


Secondary Outcome Measures :
  1. HIE: HINE [ Time Frame: 6 months, 1 year and 2 years ]
    Hammersmith Infant Neurological Examination (HINE) of the HIE Subjects

  2. HIE: HNNE [ Time Frame: -1 day, 3 months (before discharge) ]
    Hammersmith Neonatal Neurological Examination (HNNE) of the HIE Subjects

  3. HIE: GMDS [ Time Frame: 6 months, 1 year and 2 years ]
    Griffiths Mental Development Scale (GMDS) of the HIE Subjects

  4. HIE: CBCL [ Time Frame: 2 years ]
    Child Behavior Checklist for Attention Deficit of the HIE Subjects

  5. HIE: Q-CHAT [ Time Frame: 2 years ]
    Quantitative Checklist for Autism in Toddlers of the HIE Subjects

  6. Anemia: hemoglobin [ Time Frame: 48 hours, 1 week, 3 months and 6 months ]
    Change from Baseline hemoglobin of the Anemia Subjects

  7. Anemia: Oxygenation level [ Time Frame: 48 hours, 1 week ]
    Change from Baseline SpO2 of the Anemia Subjects

  8. Anemia: Oxidative Stress Level [ Time Frame: 48 hours, 1 week, 3 months, and 6 months ]
    Change of Baseline Isoprostane of the Anemia Subjects

  9. Anemia: Requirements of Packed Cell Transfusion [ Time Frame: 6 months ]
    Frequency of Requirements of Packed Cell Transfusion by the Anemia Subjects


Other Outcome Measures:
  1. Incidence of Adverse Event [ Time Frame: 2 years ]
    Safety outcomes are Incidence of Adverse Events



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Ages Eligible for Study:   up to 48 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT03352310


Contacts
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Contact: Simon Lam, MD +852 35052851 hshslam@cuhk.edu.hk
Contact: Ronald Wang, MD +852 35052810

Locations
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Hong Kong
The Chinese University of Hong Kong Recruiting
Sha Tin, Hong Kong
Contact: Simon Lam, M.D.    +852 35052851      
Principal Investigator: Simon Lam, MD         
Sub-Investigator: Ronald Wang, MD         
Sub-Investigator: Chi Kong Li, MD         
Sub-Investigator: Eva Fung, MD         
Sponsors and Collaborators
Mononuclear Therapeutics Ltd.
Chinese University of Hong Kong
China Spinal Cord Injury Network
Investigators
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Principal Investigator: Simon Lam, MD Chinese University of Hong Kong

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Responsible Party: Mononuclear Therapeutics Ltd.
ClinicalTrials.gov Identifier: NCT03352310     History of Changes
Other Study ID Numbers: UCB-HIEA-01
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Mononuclear Therapeutics Ltd.:
umbilical cord blood

Additional relevant MeSH terms:
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Anemia
Ischemia
Hypoxia
Brain Diseases
Brain Ischemia
Hypoxia-Ischemia, Brain
Cerebral Infarction
Anemia, Neonatal
Hematologic Diseases
Pathologic Processes
Signs and Symptoms, Respiratory
Signs and Symptoms
Central Nervous System Diseases
Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Hypoxia, Brain
Brain Infarction
Stroke
Infant, Newborn, Diseases