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

NCT ID: NCT03352310

Last Updated: 2018-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-16
• Study Completion Date: 2020-12-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study Group

autologous UCB transfusion

Group Type: EXPERIMENTAL

autologous umbilical cord blood (UCB)

Intervention Type: BIOLOGICAL

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

Control Group

standard care

Group Type: OTHER

standard care

Intervention Type: PROCEDURE

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

Interventions

autologous umbilical cord blood (UCB)

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

Intervention Type: BIOLOGICAL

standard care

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

Intervention Type: PROCEDURE

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

• Maximum Eligible Age: 48 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: collaborator

China Spinal Cord Injury Network

NETWORK

Sponsor Role: collaborator

Mononuclear Therapeutics Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Simon Lam, MD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

The Chinese University of Hong Kong

Shatin, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Simon Lam, MD

Role: CONTACT

hshslam@cuhk.edu.hk

+852 35052851

Ronald Wang, MD

Role: CONTACT

+852 35052810

Facility Contacts

Simon Lam, M.D.

Role: primary

+852 35052851

Other Identifiers

UCB-HIEA-01

Identifier Type: -

Identifier Source: org_study_id