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CoBIS 2: Umbilical Cord Blood for Ischemic Stroke
NCT03004976Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2017
- Primary completion
- Jul 2020
- Countries
- 1
- Sponsor
- Joanne Kurtzberg
- Modality
- Hematopoietic Stem Cells
- Drugs
- umbilical cord blood
- Conditions
- ischemic stroke
01
Overview
Phase 2, randomised, double-blind trial in ischemic stroke comparing Umbilical Cord Blood with Placebo (2 arms). Primary endpoint: Shift in Modified Rankin Scale at 3 months. Started Mar 2017; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Umbilical Cord Blood
Single IV infusion of unrelated donor UCB
Placebo
Single IV infusion of placebo
03
Who it enrols
Adults 18-90 with recent acute ischemic stroke (MCA distribution) and NIHSS 6-15 (R) or 6-20 (L). Excludes patients with significant midline shift, hemorrhage, need for craniotomy, or immunosuppression.
04
Endpoints
Primary
Shift in Modified Rankin Scale
Secondary
Number of Infusion Reactions
Number of Product-related Infections
Number of Alloimmunization Events
Number of Graft vs. Host Disease Events
Number of Study Related and Unexpected Adverse Events
Mortality
Number of Participants With Functional Independence
Shift in Modified Rankin Scale at 30 Days
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