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

NCT03352310 | Unknown Phase 1

• 1 other identifier: UCB-HIEA-01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypoxic-Ischemic Encephalopathy; Hypoxia Neonatal; Cerebral Ischemia of Newborn; Anemia, Neonatal

Keywords

umbilical cord blood

Outcome Measures

Primary Outcomes (2)

• HIE: Mortality

  Mortality Rate of the HIE Subjects

  6 months

• Anemia: Change from Baseline Hematocrit

  Change from Baseline Hematocrit of the Anemia Subjects

  48 hours, 1 week, 3 months, 6 months

Secondary Outcomes (9)

• HIE: HINE

  6 months, 1 year and 2 years

• HIE: HNNE

  -1 day, 3 months (before discharge)

• HIE: GMDS

  6 months, 1 year and 2 years

• HIE: CBCL

  2 years

• HIE: Q-CHAT

  2 years

Other Outcomes (1)

• Incidence of Adverse Event

  2 years

Study Arms (2)

Study Group

EXPERIMENTAL

autologous UCB transfusion

Biological: autologous umbilical cord blood (UCB)

Control Group

OTHER

standard care

Procedure: standard care

Interventions

autologous umbilical cord blood (UCB) BIOLOGICAL

autologous UCB transfusion to the newborn infants presence of HIE and/or anemia within 48 hours after the birth

Study Group

standard care PROCEDURE

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

Control Group

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mononuclear Therapeutics Ltd.: lead
• Chinese University of Hong Kong: collaborator
• China Spinal Cord Injury Network: collaborator

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

RECRUITING

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Asphyxia Neonatorum; Anemia, Neonatal

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Simon Lam, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simon Lam, MD

CONTACT

+852 35052851; hshslam@cuhk.edu.hk

Ronald Wang, MD

CONTACT

+852 35052810

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study Group - autologous umbilcial cord blood transfusion Control Group - standard care

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 24, 2017
• Study Start: April 16, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 30, 2020
• Last Updated: June 7, 2018

Record last verified: 2018-06

Locations

HK (1)