NCT06040476
Not Yet Recruiting
Phase 2
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
Overview
- Phase
- Phase 2
- Intervention
- hUCB
- Conditions
- Acute Ischemic Stroke
- Sponsor
- StemCyte, Inc.
- Enrollment
- 39
- Primary Endpoint
- safety-TEAE
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief 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
Detailed Description
This is a phase II study to evaluate the safety and efficacy in hUCB treatment on the patients with acute ischemic stroke (AIS).
Investigators
Eligibility Criteria
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.
Arms & Interventions
A group: hUCB treatment
Human cord blood infusion
Intervention: hUCB
Outcomes
Primary Outcomes
safety-TEAE
Time Frame: From screening to 48 weeks
Frequency and incidence of treatment-emergent adverse events (TEAEs).
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