Investigation of Neural Stem Cells in Ischemic Stroke
Investigation of Neural Stem Cells in Ischemic Stroke
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.
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.
Inclusion Criteria:

 -  Ischemic stroke that includes the supratentorial region as confirmed by CT or MRI,
 occurring within 6 to 24 months of the time that surgical intervention will be
 performed (Qualifying Stroke Event)

 -  Modified Rankin Score of 3 or 4 due to the Qualifying Stroke Event

 -  Some residual upper limb movement

 -  Sufficient cognitive and language abilities to comprehend verbal commands and to carry
 out the study assessments

 -  No medical conditions that would preclude neurosurgery with appropriate preparation
 and management.

 -  Ability to attend study visits and complete all study assessments including ability to
 provide informed consent

 Exclusion Criteria:

 -  Modified Rankin Score of >1 prior to the Qualifying Stroke Event

 -  Stroke due to hemorrhage or stroke known or suspected of being caused by, or related
 to, connective tissue disorder, congenital disorder of the cerebral vessels or a
 disorder of thrombosis; patients with atrial fibrillation as a suspected cause of
 stroke are NOT excluded

 -  Neurosurgical pathway obstructed by vascular malformation or cavity

 -  History of neurological or other disease resulting in significant functional
 impairment (e.g. Parkinson's disease, motor neuron disease, moderate dementia,
 arthritis, contractures or fixed anatomical abnormality)

 -  Inability to stop or transition off valproic acid or other demethylating agents or
 Histone deacetylases (HDAC) inhibitors for 1 week before and 4 weeks after surgery

 -  Use of selective serotonin reuptake inhibitors (SSRI), unless the subject is on a
 stable dose that has been started at least 2-months before screening (V1)

 -  Use of antispasticity medications (excluding oral antispasticity medications if they
 have been taken regularly for at least one month prior to surgery)The use of Botox® or
 similar is allowed if the last dose was ≥3 months prior to screening; however, its use
 will be prohibited until following the 12 month visit

 -  Inability to discontinue anticoagulation therapy for a required interval

 -  History of malignant disease within the last 5 years, or any history of primary or
 secondary brain malignant disease

 -  Patients who have previously participated in a cell-based therapy study at any time or
 in any other study involving an investigational product or rehabilitation study within
 the last 30 days

 -  Patients with clinically significant lab values, including positive Class I human
 leukocyte antigen (HLA) antibodies specific for CTX0E03

 -  Planned initiation of any new PT regimen within 6-months of surgery