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

Hypoxic-Ischemic Encephalopathy Clinical Trial

Official title:

Umbilical Cord Blood Mononuclear Cell Bank in Hong Kong and Treatment of Neonatal Cerebral Ischemia and Anemia - Part IV Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03352310
• Other study ID #: UCB-HIEA-01
• Status: Recruiting
• Phase: Phase 1
• Start date: April 16, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: June 2018
• Source: Mononuclear Therapeutics Ltd.
• Contact: Simon Lam, MD
• Phone: +852 35052851
• Email: hshslam[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 48 Hours

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Neonatal
• Brain Diseases
• Brain Ischemia
• Cerebral Infarction
• Cerebral Ischemia of Newborn
• Hypoxia
• Hypoxia Neonatal
• Hypoxia-Ischemia, Brain
• Hypoxic-Ischemic Encephalopathy
• Ischemia

Intervention

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

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

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Sha Tin

Sponsors (3)

Lead Sponsor	Collaborator
Mononuclear Therapeutics Ltd.	China Spinal Cord Injury Network, Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of Adverse Event	Safety outcomes are Incidence of Adverse Events	2 years
Primary	HIE: Mortality	Mortality Rate of the HIE Subjects	6 months
Primary	Anemia: Change from Baseline Hematocrit	Change from Baseline Hematocrit of the Anemia Subjects	48 hours, 1 week, 3 months, 6 months
Secondary	HIE: HINE	Hammersmith Infant Neurological Examination (HINE) of the HIE Subjects	6 months, 1 year and 2 years
Secondary	HIE: HNNE	Hammersmith Neonatal Neurological Examination (HNNE) of the HIE Subjects	-1 day, 3 months (before discharge)
Secondary	HIE: GMDS	Griffiths Mental Development Scale (GMDS) of the HIE Subjects	6 months, 1 year and 2 years
Secondary	HIE: CBCL	Child Behavior Checklist for Attention Deficit of the HIE Subjects	2 years
Secondary	HIE: Q-CHAT	Quantitative Checklist for Autism in Toddlers of the HIE Subjects	2 years
Secondary	Anemia: hemoglobin	Change from Baseline hemoglobin of the Anemia Subjects	48 hours, 1 week, 3 months and 6 months
Secondary	Anemia: Oxygenation level	Change from Baseline SpO2 of the Anemia Subjects	48 hours, 1 week
Secondary	Anemia: Oxidative Stress Level	Change of Baseline Isoprostane of the Anemia Subjects	48 hours, 1 week, 3 months, and 6 months
Secondary	Anemia: Requirements of Packed Cell Transfusion	Frequency of Requirements of Packed Cell Transfusion by the Anemia Subjects	6 months