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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2028-08-31

Brief Summary

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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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Detailed Description

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

Conditions

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Acute Ischemic Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A group: hUCB treatment

Human cord blood infusion

Group Type EXPERIMENTAL

hUCB

Intervention Type BIOLOGICAL

hUCB

B group: Placebo treatment

Placebo infusion

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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hUCB

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No