A Randomized Placebo-Controlled Study of the Efficacy and Safety of Intracerebral Stem Cells (CTX0E03) in Subjects with Disability Following an Ischemic Stroke

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Updated on 19 February 2024

Summary

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

Description

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. 

FAQ


Details
Condition Stroke
Age 18years - 99years
Clinical Study Identifier03629275
Last Modified on19 February 2024

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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