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

StemCyte

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: Acute Ischemic Stroke

Treatments: Biological: hUCB

Study type: Interventional

Funder types: Industry

Identifiers

NCT06040476

SCAS001

Details and patient eligibility

About

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

Full description

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

Enrollment: 39 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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39 participants in 2 patient groups

A group: hUCB treatment

Experimental group

Description:

Human cord blood infusion

Treatment:

Biological: hUCB

B group: Placebo treatment

No Intervention group

Description:

Placebo infusion