Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy

NCT02256618 | Completed Phase 1 DMC

• 1 other identifier: UMIN000014903
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 6

Brief Summary

This is a pilot study to test feasibility and safety of intravenous infusion of autologous umbilical cord blood cells in the first 72 hours after birth if a neonate is born with signs of encephalopathy.

Conditions

Neonatal Encephalopathy; Hypoxic-ischemic Encephalopathy

Keywords

neonatal encephalopathy; hypoxic-ischemic encephalopathy; newborn infants; neonates; umbilical cord blood cells

Outcome Measures

Primary Outcomes (1)

• Adverse event rates

  Adverse event rates (combined rate of death, continuous respiratory support, and continuous use of vasopressor) will be compared between the cell recipients and historical controls at 30 days of age.

  first 30 postnatal days

Secondary Outcomes (1)

• Efficacy

  18 months

Study Arms (1)

Cell therapy

EXPERIMENTAL

Infants who are born at the study sites, have moderate to severe encephalopathy, and have cord blood available for infusion

Other: Autologous umbilical cord blood cells

Interventions

Autologous umbilical cord blood cells OTHER

Autologous non-cryopreserved volume- and red blood cell-reduced cord blood cells will be intravenously infused

Cell therapy

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• ≥36 weeks gestation
• Either a 10-minute Apgar score ≤5, continued need for resuscitation for at least 10 minutes, or severe acidosis, defined as pH \<7.0 or base deficit ≥16 mmol/L in a sample of umbilical cord blood or any blood during the first hour after birth
• Moderate to severe encephalopathy (Sarnat II to III)
• A moderately or severely abnormal background amplitude-integrated EEG (aEEG) voltage, or seizures identified by aEEG, if monitored
• Up to 24 hours of age
• Autologous umbilical cord blood available to infuse within 3 days after birth
• A person with parental authority must have consented for the study.

You may not qualify if:

• Known major congenital anomalies, such as chromosomal anomalies, heart diseases
• Major intracranial hemorrhage identified by brain ultrasonography or computed tomography
• Severe growth restriction, with birth-weight less than 1800 g
• Severe infectious disease, such as sepsis
• Hyperkalemia
• Outborn infants (Infants born at hospitals other than the study sites)
• Volume of collected cord blood \<40 ml
• Infants judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist

Sponsors & Collaborators

• Neonatal Encephalopathy Consortium, Japan: lead
• Osaka City University: collaborator
• Yodogawa Christian Hospital: collaborator
• Kurashiki Central Hospital: collaborator
• Nagoya University: collaborator
• Osaka City General Hospital: collaborator
• Saitama Medical University: collaborator
• National Cerebral and Cardiovascular Center, Japan: collaborator
• National Center for Child Health and Development, Japan: collaborator
• Tokyo University: collaborator
• Tokyo Women's Medical University: collaborator

Study Sites (6)

Nagoya University Hospital

Nagoya, Aichi-ken, 466-8560, Japan

Location

Kurashiki Central Hospital

Kurashiki, Okayama-ken, 710-8602, Japan

Location

Saitama Medical University

Kawagoe, Saitama, 350-0495, Japan

Location

Yodogawa Christian Hospital

Osaka, 533-0032, Japan

Location

Osaka City General Hospital

Osaka, 534-0021, Japan

Location

Osaka City University

Osaka, 545-8585, Japan

Location

Related Publications (3)

• Tsuji M, Taguchi A, Ohshima M, Kasahara Y, Sato Y, Tsuda H, Otani K, Yamahara K, Ihara M, Harada-Shiba M, Ikeda T, Matsuyama T. Effects of intravenous administration of umbilical cord blood CD34(+) cells in a mouse model of neonatal stroke. Neuroscience. 2014 Mar 28;263:148-58. doi: 10.1016/j.neuroscience.2014.01.018. Epub 2014 Jan 18.

  PMID: 24444827 BACKGROUND

• Ohshima M, Taguchi A, Tsuda H, Sato Y, Yamahara K, Harada-Shiba M, Miyazato M, Ikeda T, Iida H, Tsuji M. Intraperitoneal and intravenous deliveries are not comparable in terms of drug efficacy and cell distribution in neonatal mice with hypoxia-ischemia. Brain Dev. 2015 Apr;37(4):376-86. doi: 10.1016/j.braindev.2014.06.010. Epub 2014 Jul 14.

  PMID: 25034178 BACKGROUND

• Taguchi A, Soma T, Tanaka H, Kanda T, Nishimura H, Yoshikawa H, Tsukamoto Y, Iso H, Fujimori Y, Stern DM, Naritomi H, Matsuyama T. Administration of CD34+ cells after stroke enhances neurogenesis via angiogenesis in a mouse model. J Clin Invest. 2004 Aug;114(3):330-8. doi: 10.1172/JCI20622.

  PMID: 15286799 BACKGROUND

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Haruo Shintaku, MD, PhD

  Osaka City University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 3, 2014
• Study Start: August 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: July 1, 2019
• Last Updated: October 29, 2019

Record last verified: 2019-10

Locations

JP (6)