Investigation of Neural Stem Cells in Ischemic Stroke

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.

Inclusion Criteria:

- Ischemic stroke that includes the supratentorial region as confirmed by CT or MRI,
occurring within 6 to 12 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 four months prior to surgery)

- 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