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NCT06040476 Clinical Trial

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

Acute Ischemic Stroke Clinical Trial

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06040476
Other study ID # SCAS001
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date September 2024
Est. completion date August 2027

Study information
Verified date September 2023
Source StemCyte International, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 39
Est. completion date August 2027
Est. primary completion date January 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• hUCB
hUCB

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
StemCyte Taiwan Co., Ltd.

Outcome
Type Measure Description Time frame Safety issue
Primary safety-TEAE Frequency and incidence of treatment-emergent adverse events (TEAEs). From screening to 48 weeks
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