The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells

Sponsor:

Collaborators:

Information provided by (Responsible Party):

yangjie，Guangdong Women and Children Hospital

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

November 1, 2018

Estimated Primary Completion Date

September 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

safety of autologous umbilical cord blood stem cells infusion in enrolled preterm infants[ Time Frame: during infusion 24 hours after infusion ]

Adverse event rates occurring will be compared between the autologous umbilical cord blood stem cells recipients and control group

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

effect of autologous umbilical cord blood stem cells infusion in enrolled preterm infants[ Time Frame: 1 year ]
the effect of autologous umbilical cord blood stem cells infusion will be measured by neurodevelopmental function at 4 - 6 months and 9 - 12 months of age

Descriptive Information

Brief Title ^ICMJE

The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells

Official Title ^ICMJE

The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells

Brief Summary

To study the safety and effect of autologous umbilical cord blood stem cells for treatment brain injury

Detailed Description

The purpose of this study is to evaluate the safety and effect of infusions of autologous (the patient's own)umbilical cord blood stem cells in newborn infants with hypoxic-ischemic encephalopathy. For this study, infants who have signs of moderate to severe encephalopathy at birth whose mothers have previously consented to providing cord blood stem cells for the Gunagdong Cord Blood Bank,or provided verbal consent for cord blood collection for the possibility of their baby's participation in this trial, can receive their own cord blood stem cells if an adequate number of cells that meet Guangdong Cord Blood Bank Quality standards are available in the first 14 postnatal days. Study activities also include serial blood draws concurrent with clinically indicated blood draws with a total volume of no more than 5 milliliters (1 teaspoon) from all study related tests. Babies will be followed for neurodevelopmental outcome at 4 - 6 and 9 - 12 months. MRI's will be obtained per clinical routine and results will be analyzed and described in study reports.

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Other: autologous umbilical cord blood stem cells
autologous umbilical cord blood stem cells treatment for brain injury for safety and effect evaluation
Drug: 0.9% Sodium-chloride
0.9% Sodium-chloride in control group

Study Arms

Placebo Comparator: Placebo
preterm infants with severe hypoxic ischemic encephalopathy receive only 0.9% Sodium-chloride
Experimental: infusion
preterm infants with severe hypoxic ischemic encephalopathy will receive up to 4 infusions of their own volume reduced cord blood stem cells. The number of doses will be determined by the amount of available cord blood stem cells. The dose for each infusion is 5x107 cells/kg

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

200

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

September 1, 2021

Estimated Primary Completion Date

September 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Mothers must have consented for cord blood collection at delivery - cord blood must be available for extraction of stem cells. ->28 weeks gestation,<37weeks gestation - cord or neonatal pH<7.0 or base deficit>16 milliequivalents per liter (mEq/L) or history of acute perinatal event - either a 10 minute Apgar < 5 or continued need for ventilation. - All infants must have signs of encephalopathy within 6 hours of age. Exclusion Criteria: - Presence of known chromosomal anomaly. - Presence of major congenital anomalies. - Severe intrauterine growth restriction (weight <1800g) - Infants in extremis for whom no additional intensive therapy will be offered by attending neonatologist. - Parents refuse consent. - Attending neonatologist refuses consent. - Failure to collect the infant's cord blood and/or laboratory unable to process cord blood.

Sex/Gender

Sexes Eligible for Study:

All

Ages

28 Weeks and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

yangjie，Guangdong Women and Children Hospital

Study Sponsor ^ICMJE

Guangdong Women and Children Hospital

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Jie Yang, PHD Gunagzhou,Guangdong,China,511442

PRS Account

Guangdong Women and Children Hospital

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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