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Human Umbilical Cord Blood Infusion in Patients With Acute Ischemic Stroke (AIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06040476
Recruitment Status : Not yet recruiting
First Posted : September 15, 2023
Last Update Posted : April 18, 2024
Sponsor:
Information provided by (Responsible Party):
StemCyte International, Ltd. ( StemCyte Taiwan Co., Ltd. )

Study Description
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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

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Biological: hUCB Phase 2

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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : September 2024
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : August 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Arms and Interventions
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Arm Intervention/treatment
Experimental: A group: hUCB treatment
Human cord blood infusion
 Biological: hUCB
hUCB
No Intervention: B group: Placebo treatment
Placebo infusion


Outcome Measures
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Primary Outcome Measures :
  1. safety-TEAE [ Time Frame: From screening to 48 weeks ]
    Frequency and incidence of treatment-emergent adverse events (TEAEs).


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: StemCyte Taiwan Co., Ltd.
ClinicalTrials.gov Identifier: NCT06040476    
Other Study ID Numbers: SCAS001
First Posted: September 15, 2023    Key Record Dates
Last Update Posted: April 18, 2024
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stroke
Ischemic Stroke
Cerebral Infarction
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Infarction
Necrosis