eonatal Encephalopathy New Therapy by Autologous cord blood stem cells in Japa

Phase 2

Recruiting

• Conditions: eonatal hypoxic ischemic encephalopathy

• Registration Number: JPRN-jRCTb050200084
• Lead Sponsor: SHINTAKU HARUO

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

At the time of enrollment, subjects who meet all the following selection criteria but do not fall under any of the exclusion criteria are eligible.
1. Born over 36 weeks of gestational age.
Match one of the following:
1) Apgar score of 10 minutes after birth is 5 or less.
2) Continuous neonatal resuscitation of 10 minutes or more is necessary.
3) Severe acidosis (pH less than 7.0 , or base deficit more than 16 mmol/L in blood gas) at birth (within 1 hour of birth).
3. Moderate or severe encephalopathy (Sarnat classification II to III degree) or seizure are recognized.
4. Autologous cord blood is collected and stored, and cord blood can be administered within 12~24 hours after birth.
5. Written consent has been obtained from the parent of the patient.

Exclusion Criteria

1. Head echo or CT shows severe intracranial hemorrhage.
2. Birth weight is less than 1800g.
3. Serious infections are occurring.
4. After being born outside this research related hospitals, they are ambulanced to the research related hospitals.
5 cord blood collection volume is less than 40 ml.
6 I am dying and I can not expect the benefit of the child by intensive care including hypothermia. Or, at the discretion of the attending physician, entry into this study may be considered inappropriate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified