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

Mononuclear Therapeutics

Status and phase: Unknown; Phase 1

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

Treatments: Biological: autologous umbilical cord blood (UCB); Procedure: standard care

Study type: Interventional

Funder types: Other; NETWORK; Industry

Identifiers

NCT03352310

UCB-HIEA-01

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: Under 48 hours old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Study Group

Experimental group

Description:

autologous UCB transfusion

Treatment:

Biological: autologous umbilical cord blood (UCB)

Control Group

Other group

Description:

standard care

Treatment:

Procedure: standard care