A Randomized Placebo-Controlled Study of the Efficacy and Safety of Intracerebral Stem Cells (CTX0E03) in Subjects with Disability Following an Ischemic Stroke
Brief description of study
The research study is being conducted to find out if this study drug provides any improvement in
the arm and/or leg function affected by the stroke. The study will also gather more information about the
safety of the study drug, surgical procedure and equipment used to inject the study drug. The study drug
is called CTX0E03 DP and is made from stem cells. The study drug, including the equipment being used
to give the stem cells, is experimental and will be injected into the brain
Detailed description of study
If you agree to join the study, following confirmation of eligibility criteria, you will be
randomized in 2:1 ratio to receive either a single administration of CTX0E03 DP by intracerebral
implantation or receive placebo surgery only. Subjects will be followed for 12 months after study drug
administration or placebo surgery with follow-up assessments occurring at Day 1, 7, and Months 1, 3, 6,
9, and 12. All eligible subjects will be assigned a standardized PT program based on their baseline
functional impairment. Subjects will be expected to complete their PT exercises daily, and
independently or with a family member/caregiver for 12 wks post-surgery.
Your participation will last for will last approximately 1 year.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
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Conditions:
Stroke
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Age: Between 18 Years - 99 Years
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Gender: All
Updated on
04 Jul 2023.
Study ID: 832621
