Last updated on June 2019

Investigation of Neural Stem Cells in Ischemic Stroke

Brief description of study

A study of stereotactic, intracerebral injection of CTX0E03 neural stem cells into patients with moderate to moderately severe disability as a result of an ischemic stroke.

Detailed Study Description

This is a randomized, placebo-controlled, multi-center study. Patients with persistent disability 6-12 months following an ischemic stroke will be enrolled following confirmation of eligibility. Patients will be randomized 1:1 to undergo a stereotactic surgery and receive a single administration of CTX0E03 Drug Product by intracerebral implantation or undergo sham surgery only (placebo). Patients will be followed for 12 months after surgery with follow-up assessments occurring at various time points over the 12 months. All eligible patients will be assigned a standardized Physical Therapy (PT) program. Patients will complete their daily PT exercises at home for 12 weeks after their surgery.

Clinical Study Identifier: NCT03629275

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