Clinical trial NCT03352310: Feasibility and Safety of Umbilical Cord Blood Transfusion in the Treatment of Neonatal Cerebral Ischemia and Anemia
Official title: Umbilical Cord Blood Mononuclear Cell Bank in Hong Kong and Treatment of Neonatal Cerebral Ischemia and Anemia - Part IV Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Hypoxic-Ischemic Encephalopathy
Hypoxia Neonatal
Cerebral Ischemia of Newborn
Anemia, Neonatal
Keywords: umbilical cord blood
Lead sponsor: Mononuclear Therapeutics Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Chinese University of Hong Kong
name: China Spinal Cord Injury Network
First posted: 2017-11-24
Enrollment: 40
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study Group - autologous umbilcial cord blood transfusion

Control Group - standard care
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: HIE: Mortality
timeFrame: 6 months
measure: Anemia: Change from Baseline Hematocrit
timeFrame: 48 hours, 1 week, 3 months, 6 months
Secondary outcomes:
measure: HIE: HINE
timeFrame: 6 months, 1 year and 2 years
measure: HIE: HNNE
timeFrame: -1 day, 3 months (before discharge)
measure: HIE: GMDS
timeFrame: 6 months, 1 year and 2 years
measure: HIE: CBCL
timeFrame: 2 years
measure: HIE: Q-CHAT
timeFrame: 2 years
measure: Anemia: hemoglobin
timeFrame: 48 hours, 1 week, 3 months and 6 months
measure: Anemia: Oxygenation level
timeFrame: 48 hours, 1 week
measure: Anemia: Oxidative Stress Level
timeFrame: 48 hours, 1 week, 3 months, and 6 months
measure: Anemia: Requirements of Packed Cell Transfusion
timeFrame: 6 months
Other outcomes:
measure: Incidence of Adverse Event
timeFrame: 2 years
Locations:
city: Sha Tin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Simon Lam, MD
role: PRINCIPAL_INVESTIGATOR
References: