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

Phase 2Not Yet RecruitingNCT06040476

StemCyte, Inc.39 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Acute Ischemic Stroke

Interventions

hUCBBIOLOGICAL

hUCB

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

safety-TEAE

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

Time frame: From screening to 48 weeks

Central Contacts

Ying Chieh Bobo Chen, PhD

CONTACT

02-26013013 Ext809 bobo.chen@stemcyte.com.tw

Data from ClinicalTrials.gov

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