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

Last updated: June 5, 2018
Sponsor: Mononuclear Therapeutics Ltd.
Overall Status: Active - Recruiting

Phase

1

Condition

Anemia

Stroke

Cerebral Palsy

Treatment

N/A

Clinical Study ID

NCT03352310
UCB-HIEA-01
  • Ages < 48
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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/dLwithin the first 96 hours of life;

  • obtain the informed consent from parents

Exclusion

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

Study Design

Total Participants: 40
Study Start date:
April 16, 2018
Estimated Completion Date:
December 30, 2020

Connect with a study center

  • The Chinese University of Hong Kong

    Sha Tin,
    Hong Kong

    Active - Recruiting

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