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

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ClinicalTrials.gov Identifier: NCT03696745
Recruitment Status : Not yet recruiting
First Posted : October 5, 2018
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
yangjie, Guangdong Women and Children Hospital

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

Condition or disease Intervention/treatment Phase
Safety Issues Effect of Drugs Other: autologous umbilical cord blood stem cells Drug: 0.9% Sodium-chloride Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Treatment of Premature Infants With Brain Injury by Autologous Umbilical Cord Blood Stem Cells
Estimated Study Start Date : November 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
preterm infants with severe hypoxic ischemic encephalopathy receive only 0.9% Sodium-chloride
Drug: 0.9% Sodium-chloride
0.9% Sodium-chloride in control group

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
Other: autologous umbilical cord blood stem cells
autologous umbilical cord blood stem cells treatment for brain injury for safety and effect evaluation




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   28 Weeks to 37 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696745


Contacts
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Contact: ZhuXiao Ren, MD +8613538984634 ext +86 renzhx1990@163.com
Contact: Jie Yang, PHD 39151777 ext 020 Jjieyang0830@163.com

Sponsors and Collaborators
Guangdong Women and Children Hospital
Investigators
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Principal Investigator: Jie Yang, PHD Gunagzhou,Guangdong,China,511442

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Responsible Party: yangjie, Professor, Guangdong Women and Children Hospital
ClinicalTrials.gov Identifier: NCT03696745     History of Changes
Other Study ID Numbers: GuangdongW C H
First Posted: October 5, 2018    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by yangjie, Guangdong Women and Children Hospital:
Autologous Umbilical Cord Blood Stem Cells
Safety
Effect
brain injury

Additional relevant MeSH terms:
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Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries