Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke (AIS)

A Phase II, Randomized, Double-blind, Parallel, Placebo-controlled Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke

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Key information

Conditions

Acute Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

This is a phase II study to evaluate the safety and efficacy in hUCB treatment on the patients with acute ischemic stroke (AIS).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Male or female subject ≥18 and ≤80 years of age.
Subject with a confirmed diagnosis of AIS and hemiplegia

Exclusion criteria

Subject with known immune disease, immunodeficiency, or receives immunosuppressive therapy/immunomodulators within 4 weeks or 5 half-lives prior to screening, whichever is longer.

Treatment and study plan

hUCB

Biological

hUCB

Primary outcomes

safety-TEAE

Time frame: From screening to 48 weeks

Frequency and incidence of treatment-emergent adverse events (TEAEs).

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Chieh Bobo Chen, PhD

CONTACT

[email protected]

02-26013013 Ext809

Sponsors and collaborators

Lead sponsor

StemCyte, Inc.

Industry

Collaborators

StemCyte Taiwan Co., Ltd.

Registry information

Official study title

A Phase II, Randomized, Double-blind, Parallel, Placebo-controlled Study to Assess the Safety and Efficacy of Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2028
First posted: Sep 15, 2023
Registry last updated: Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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