Human Umbilical Cord Blood Infusion in Patients with Acute Ischemic Stroke (AIS)
ConditionAcute Ischemic Stroke
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorStemCyte, Inc.
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female subject ≥18 and ≤80 years of age.
Subject with a confirmed diagnosis of AIS and hemiplegia
Disqualifiers
Subject with known immune disease, immunodeficiency, or receives immunosuppressive therapy/immunomodulators within 4 weeks or 5 half-lives prior to screening, whichever is longer.
Trial design
Design model
Parallel
Treatments tested in this trial
hUCB
Biological/VaccinehUCB
Treatment groups
39 Participants
are divided into 2 treatment groupsGroup A: A group: hUCB treatmentExperimental treatment 1 intervention
Group B: B group: Placebo treatmentNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
safety-TEAE
Frequency and incidence of treatment-emergent adverse events (TEAEs).
Time frame
From screening to 48 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
StemCyte, Inc.
Lead sponsor
StemCyte Taiwan Co., Ltd.
Collaborator
Source ClinicalTrials.gov
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