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The Clinical Trial of CL2020 Cells for Neonatal Hypoxic Ischemic Encephalopathy

NCT04261335 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-10-03

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and the tolerability of CL2020 cells in hypoxic ischemic encephalopathy neonates with hypothermia therapy. In addition, we will evaluate the efficacy of CL2020 cells for infant development.

Conditions

  • Hypoxia-Ischemia, Brain

Interventions

BIOLOGICAL

CL2020 cells

1.5 million or 15 million cells, IV on day 5 to 14 of birth

Sponsors & Collaborators

  • Life Science Institute, Inc.

    collaborator UNKNOWN

  • Nagoya University

    lead OTHER

Principal Investigators

  • Yoshiaki Sato, MD, PhD · Department of Center for Maternal Neonatal Care, Nagoya University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Days
Max Age
14 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-04
Primary Completion
2021-09-29
Completion
2022-12-12

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04261335 on ClinicalTrials.gov