Status:
UNKNOWN
Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia
Lead Sponsor:
Mononuclear Therapeutics Ltd.
Collaborating Sponsors:
Chinese University of Hong Kong
China Spinal Cord Injury Network
Conditions:
Hypoxic-Ischemic Encephalopathy
Hypoxia Neonatal
Eligibility:
All Genders
Up to 48 years
Phase:
PHASE1
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 en...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2020
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03352310
Start Date
April 16 2018
End Date
December 30 2020
Last Update
June 7 2018
Active Locations (1)
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1
The Chinese University of Hong Kong
Shatin, Hong Kong