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

Phase 1

• Conditions: Hypoxic-Ischemic Encephalopathy; Hypoxia Neonatal; Cerebral Ischemia of Newborn; Anemia, Neonatal
• Interventions: Biological: autologous umbilical cord blood (UCB); Procedure: standard care

• Registration Number: NCT03352310
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-15
• Study First Submitted QC: 2017-11-21
• Study First Posted: 2017-11-24
• Study Start: 2018-04-16
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-05
• Last Update Posted: 2018-06-07
• Primary Completion: 2020-06-30
• Study Completion: 2020-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study Group	autologous umbilical cord blood (UCB)	autologous UCB transfusion
Control Group	standard care	standard care

Primary Outcome Measures

Name	Time	Method
Anemia: Change from Baseline Hematocrit	48 hours, 1 week, 3 months, 6 months	Change from Baseline Hematocrit of the Anemia Subjects
HIE: Mortality	6 months	Mortality Rate of the HIE Subjects

Secondary Outcome Measures

Name	Time	Method
Anemia: Requirements of Packed Cell Transfusion	6 months	Frequency of Requirements of Packed Cell Transfusion by the Anemia Subjects
Anemia: Oxygenation level	48 hours, 1 week	Change from Baseline SpO2 of the Anemia Subjects
Anemia: Oxidative Stress Level	48 hours, 1 week, 3 months, and 6 months	Change of Baseline Isoprostane of the Anemia Subjects
HIE: GMDS	6 months, 1 year and 2 years	Griffiths Mental Development Scale (GMDS) of the HIE Subjects
HIE: HINE	6 months, 1 year and 2 years	Hammersmith Infant Neurological Examination (HINE) of the HIE Subjects
HIE: HNNE	-1 day, 3 months (before discharge)	Hammersmith Neonatal Neurological Examination (HNNE) of the HIE Subjects
HIE: Q-CHAT	2 years	Quantitative Checklist for Autism in Toddlers of the HIE Subjects
HIE: CBCL	2 years	Child Behavior Checklist for Attention Deficit of the HIE Subjects
Anemia: hemoglobin	48 hours, 1 week, 3 months and 6 months	Change from Baseline hemoglobin of the Anemia Subjects

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Sha Tin, Hong Kong