Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke

Inclusion Criteria

• Age 18-75 years, inclusive
• Documented history of completed ischemic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement, with correlated findings by MRI
• Between 6 and 90 months (7.5 years) post-stroke, and having a chronic motor neurological deficit
• Neurological motor deficit substantially due to incident stroke
• Modified Rankin Score of 2-4
• Require Motricity Index 30-75 (UE Scale) or 27-74 (LE Scale)
• Able to undergo all planned neurological assessments
• Able and willing to undergo magneti resonance imaging (MRI) with contrast and computed tomography (CT)
• Agree that use of antiplatelet, anti-coagulant, or non-steroidal anti-inflammatory drugs to be determined by the local medical staff and in accordance with the ACCP 2012 guideline "Perioperative Management of Antithrombotic Therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th Edition: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines", if applicable , provided that no antiplatelet, anti-coagulant, or non-steroidal anti-inflammatory drugs are to be restarted post-surgery until after the Day 8 MRI is read and are determined to be safe to re-start
• Subjects must have had physical therapy prior to entry (and be willing to continue to the extent possible)
• Must be willing to discontinue herbal or non-traditional medicines for 1 week before and 1 week after the surgical procedure and be willing to continue to the extent possible
• Ability of patient or legal authorized representative to understand and sign an Informed Consent

Exclusion Criteria

• History or presence of any other major neurological disease other than stroke
• Cerebral infarct size >150 cm3 measured by MRI
• Primary intracerebral hemorrhage
• Myocardial infarction within prior 6 mos.
• Malignancy unless in remission >5 yrs.
• Clinically significant finding on MRI of brain not related to stroke
• Any seizures in the 3 months prior to Screening
• More than 5 degrees of contracture at shoulder, elbow, wrist, fingers, hip, knee and ankle
• Other neurologic, neuromuscular or orthopedic disease that limits motor function
• Uncontrolled systemic illness, including, but not limited to: hypertension; diabetes; renal, hepatic, or cardiac failure
• Positive findings on tests for occult malignancy, unless a non-malignant etiology is confirmed
• Uncontrolled major psychiatric illness, including depression symptoms (CESD R Scale of ≥16 is exclusionary)
• Total bilirubin >1.9 mg/dL at Screening
• Serum creatinine >1.5 mg/dL at Screening
• Hemoglobin 11.5 mg/dL at Screening
• International Normalized Ratio of Prothrombin Time (INR) >1.2 at Screening if the patient does not take anticoagulants; for patients on anticoagulants, INR must be confirmed to be ≤1.2 prior to surgery
• Presence of craniectomy or other contraindication to stereotactic surgery
• Participation in any other investigational trial within 4 weeks of initial screening and within 7 weeks of Baseline visit
• Botulinum toxin injection, phenol injection, intrathecal baclofen, or any other interventional treatments for spasticity (except bracing and splinting) 16 weeks prior to the Baseline visit
• Substance use disorder (per DSM-V criteria, including drug or alcohol)
• Contraindications to head MRI (with constrast) or CT
• Pregnant or lactating
• Female patients of childbearing potential unwilling to use an adequate birth control method during the 12 months of the study
• Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study
• Any prior SB623 cell implantation and/or any prior stem cell treatment for stroke or other reason regardless of mode of administration