Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke (AIS)
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
1 other identifier
interventional
39
0 countries
N/A
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2025
Typical duration for phase_2
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2023
CompletedFirst Posted
Study publicly available on registry
September 15, 2023
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
February 27, 2025
February 1, 2025
2.2 years
August 31, 2023
February 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
safety-TEAE
Frequency and incidence of treatment-emergent adverse events (TEAEs).
From screening to 48 weeks
Study Arms (2)
A group: hUCB treatment
EXPERIMENTALHuman cord blood infusion
B group: Placebo treatment
NO INTERVENTIONPlacebo infusion
Interventions
Eligibility Criteria
You may qualify if:
- Male or female subject ≥18 and ≤80 years of age.
- Subject with a confirmed diagnosis of AIS and hemiplegia
You may not qualify if:
- Subject with known immune disease, immunodeficiency, or receives immunosuppressive therapy/immunomodulators within 4 weeks or 5 half-lives prior to screening, whichever is longer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- StemCyte, Inc.lead
- StemCyte Taiwan Co., Ltd.collaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2023
First Posted
September 15, 2023
Study Start
September 1, 2025
Primary Completion (Estimated)
December 1, 2027
Study Completion (Estimated)
August 1, 2028
Last Updated
February 27, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share