Back to resultsHuman Umbilical Cord Blood Infusion in Patients With Acute Ischemic Stroke (AIS)
Primary Purpose
Acute Ischemic Stroke
Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
hUCB
Sponsored by
About this trial
This is an interventional treatment trial for Acute Ischemic Stroke
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
A group: hUCB treatment
B group: Placebo treatment
Arm Description
Human cord blood infusion
Placebo infusion
Outcomes
Primary Outcome Measures
safety-TEAE
Frequency and incidence of treatment-emergent adverse events (TEAEs).
Secondary Outcome Measures
Full Information
NCT ID
NCT06040476
First Posted
August 31, 2023
Last Updated
September 13, 2023
Sponsor
StemCyte Taiwan Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT06040476
Brief Title
Human Umbilical Cord Blood Infusion in Patients With Acute Ischemic Stroke (AIS)
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
August 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
StemCyte Taiwan Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
39 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
A group: hUCB treatment
Arm Type
Experimental
Arm Description
Human cord blood infusion
Arm Title
B group: Placebo treatment
Arm Type
No Intervention
Arm Description
Placebo infusion
Intervention Type
Biological
Intervention Name(s)
hUCB
Intervention Description
hUCB
Primary Outcome Measure Information:
Title
safety-TEAE
Description
Frequency and incidence of treatment-emergent adverse events (TEAEs).
Time Frame
From screening to 48 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Learn more about this trial
Human Umbilical Cord Blood Infusion in Patients With Acute Ischemic Stroke (AIS)
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