Acute Ischemic Stroke
Conditions
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).
Interventions
BIOLOGICALhUCB
hUCB
Sponsors
StemCyte Taiwan Co., Ltd.
StemCyte, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| safety-TEAE | From screening to 48 weeks | Frequency and incidence of treatment-emergent adverse events (TEAEs). |
Contacts
Primary ContactYing Chieh Bobo Chen, PhD
Outcome results
None listed