Autologous Cord Blood Cell Therapy for Neonatal Encephalopathy

NCT ID: NCT02256618

Last Updated: 2019-10-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2019-07-31

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.

Detailed Description

This is a multicenter pilot study to evaluate the feasibility and safety of intravenous infusions of autologous (the patient's own) umbilical cord blood cells in term gestation newborns with neonatal encephalopathy (hypoxic-ischemic encephalopathy). If a neonate is born with signs of moderate to severe encephalopathy and cooled for the encephalopathy, the neonate can receive their own non-cryopreserved volume- and red blood cell-reduced cord blood cells. The cord blood cells are divided into 3 doses and infused at 12-24, 36-48, and 60-72 hours after the birth. Infants will be followed for safety and neurodevelopmental outcome up to 18 months.

Conditions

Neonatal Encephalopathy; Hypoxic-ischemic Encephalopathy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cell therapy

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

Group Type: EXPERIMENTAL

Autologous umbilical cord blood cells

Intervention Type: OTHER

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

Interventions

Autologous umbilical cord blood cells

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. ≥36 weeks gestation

2. 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

3. Moderate to severe encephalopathy (Sarnat II to III)

4. A moderately or severely abnormal background amplitude-integrated EEG (aEEG) voltage, or seizures identified by aEEG, if monitored

5. Up to 24 hours of age

6. Autologous umbilical cord blood available to infuse within 3 days after birth

7. A person with parental authority must have consented for the study.

Exclusion Criteria

1. Known major congenital anomalies, such as chromosomal anomalies, heart diseases

2. Major intracranial hemorrhage identified by brain ultrasonography or computed tomography

3. Severe growth restriction, with birth-weight less than 1800 g

4. Severe infectious disease, such as sepsis

5. Hyperkalemia

6. Outborn infants (Infants born at hospitals other than the study sites)

7. Volume of collected cord blood <40 ml

8. Infants judged critically ill and unlikely to benefit from neonatal intensive care by the attending neonatologist

• Maximum Eligible Age: 24 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Osaka City University

OTHER

Sponsor Role: collaborator

Yodogawa Christian Hospital

OTHER

Sponsor Role: collaborator

Kurashiki Central Hospital

OTHER

Sponsor Role: collaborator

Nagoya University

OTHER

Sponsor Role: collaborator

Osaka City General Hospital

OTHER

Sponsor Role: collaborator

Saitama Medical University

OTHER

Sponsor Role: collaborator

National Cerebral and Cardiovascular Center, Japan

OTHER

Sponsor Role: collaborator

National Center for Child Health and Development, Japan

UNKNOWN

Sponsor Role: collaborator

Tokyo University

OTHER

Sponsor Role: collaborator

Tokyo Women's Medical University

OTHER

Sponsor Role: collaborator

Neonatal Encephalopathy Consortium, Japan

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haruo Shintaku, MD, PhD

Role: STUDY_DIRECTOR

Osaka City University

Locations

Nagoya University Hospital

Nagoya, Aichi-ken, Japan

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Saitama Medical University

Kawagoe, Saitama, Japan

Yodogawa Christian Hospital

Osaka, , Japan

Osaka City General Hospital

Osaka, , Japan

Osaka City University

Osaka, , Japan

Countries

Japan

References

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.

Reference Type: BACKGROUND

PMID: 24444827 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25034178 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 15286799 (View on PubMed)

Other Identifiers

UMIN000014903

Identifier Type: -

Identifier Source: org_study_id