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Investigation of Neural Stem Cells in Ischemic Stroke — PISCES III  

Ischemic Stroke Clinical Trial

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

Clinical Trial Summary

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.

Clinical Trial Description

This is a randomized, placebo-controlled, multi-center study. Patients with persistent disability 6-24 months following an ischemic stroke will be enrolled following confirmation of eligibility. Patients will be randomized 2:1 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03629275
Study type Interventional
Source ReNeuron Limited
Contact
Status Terminated
Phase Phase 2
Start date August 31, 2018
Completion date March 2, 2021
View Details
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