Autologous Cord Blood Cells for Brain Injury in Term Newborns

Hypoxic Ischemic Encephalopathy Clinical Trial

Official title:

Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy: Phase I Study of Feasibility and Safety

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01649648
• Other study ID #: NMRC/EDG/1032/2, EDG09nov061
• Status: Completed
• Phase: Phase 1
• First received: July 23, 2012
• Last updated: January 25, 2017
• Start date: September 2011
• Est. completion date: November 2015

Study information

• Verified date: April 2012
• Source: National University Hospital, Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a pilot study to test feasibility and safety of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood during the first 3 days of age if the baby is born with signs of brain injury. The cord blood used is fresh (not frozen and then thawed).

Description:

The purpose of this pilot study is to evaluate the safety and feasibility of infusions of autologous (the patient's own) umbilical cord blood cells in term gestation newborn infants with hypoxic-ischemic encephalopathy. For this study, infants who have signs of moderate to severe encephalopathy at birth and have cord blood collected at birth can receive their own cord blood cells during the 3 days of age. Babies will be followed for neurodevelopmental outcome at 1, 4 - 6, 9 - 12 months and 18-24 months. MRI brain will be obtained at 1-2 weeks and 4-6 months old.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: November 2015
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Days

Eligibility

Inclusion Criteria:

1. Autologous umbilical cord blood available

2. >36 weeks gestation

3. Brain injury that satisfies criteria for therapeutic hypothermia

4. Parental informed consent

Exclusion Criteria:

1. Inability to enroll by 3 postnatal days of age.

2. Presence of known chromosomal anomaly.

3. Presence of major congenital anomalies.

4. Severe intrauterine growth restriction

5. Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist.

6. Parents refuse consent.

7. Attending neonatologist refuses consent.

8. Failure to collect the infant's cord blood and/or laboratory unable to process cord blood

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypoxia-Ischemia, Brain
• Hypoxic Ischemic Encephalopathy
• Ischemia

Intervention

Biological:
• Autologous cord blood
Baby's own umbilical cord blood

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore
Singapore	National University Hospital	Singapore
Singapore	Singapore General Hospital	Singapore

Sponsors (2)

Lead Sponsor	Collaborator
National University Hospital, Singapore	National Medical Research Council (NMRC), Singapore

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety	Adverse event rates occurring in the recipients	1-3 days of age
Secondary	Neurodevelopment	Peabody tests, Bayley Scales of Infant Development	1 month-2 years old
Secondary	Brain imaging	MRI brain at 1-2 weeks old and 4-6 months old	1 week-6 months