Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke (AIS)
Phase 2
Not yet recruiting
- Conditions
- Acute Ischemic Stroke
- Interventions
- Biological: hUCB
- Registration Number
- NCT06040476
- Lead Sponsor
- StemCyte, Inc.
- 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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 39
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A group: hUCB treatment hUCB Human cord blood infusion
- Primary Outcome Measures
Name Time Method safety-TEAE From screening to 48 weeks Frequency and incidence of treatment-emergent adverse events (TEAEs).
- Secondary Outcome Measures
Name Time Method