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

NCT03696745 | Unknown Phase 1

• 1 other identifier: GuangdongW C H
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Safety Issues; Effect of Drugs

Keywords

Autologous Umbilical Cord Blood Stem Cells; Safety; Effect; brain injury

Outcome Measures

Primary Outcomes (1)

• safety of autologous umbilical cord blood stem cells infusion in enrolled preterm infants

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

  during infusion 24 hours after infusion

Secondary Outcomes (1)

• effect of autologous umbilical cord blood stem cells infusion in enrolled preterm infants

  1 year

Study Arms (2)

Placebo

PLACEBO COMPARATOR

preterm infants with severe hypoxic ischemic encephalopathy receive only 0.9% Sodium-chloride

Drug: 0.9% Sodium-chloride

infusion

EXPERIMENTAL

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

Interventions

autologous umbilical cord blood stem cells OTHER

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

infusion

0.9% Sodium-chloride DRUG

0.9% Sodium-chloride in control group

Placebo

Eligibility Criteria

• Age: 28 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangdong Women and Children Hospital: lead

MeSH Terms

Conditions

Brain Injuries

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Jie Yang, PHD

  Gunagzhou,Guangdong,China,511442

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ZhuXiao Ren, MD

CONTACT

+8613538984634; renzhx1990@163.com

Jie Yang, PHD

CONTACT

39151777; Jjieyang0830@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 5, 2018
• Study Start: November 1, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2021
• Last Updated: October 5, 2018

Record last verified: 2018-10