Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke
Condition: Chronic Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Intervention: SB623 Implant (2.5M); SB623 Implant (5.0M); Sham surgery
Intervention description: 2.5 million SB623 cells; 5 million SB623 cells
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 163.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: ischemic stroke; chronic stroke; fixed motor deficits

Summary:

      Controlled study of stereotactic, intracranial injection of SB623 cells in patients with
      fixed motor deficits from ischemic stroke
    

Eligibility criteria:

        Inclusion Criteria:

          1. Age 18-75 years, inclusive

          2. Documented history of completed ischemic stroke in subcortical region of MCA or
             lenticulostriate artery with or without cortical involvement, with correlated findings
             by MRI

          3. Between 6 and 90 months (7.5 years) post-stroke, and having a chronic motor
             neurological deficit

          4. Neurological motor deficit substantially due to incident stroke

          5. Modified Rankin Score of 2-4

          6. Require Motricity Index 30-75 (UE Scale) or 27-74 (LE Scale)

          7. Able to undergo all planned neurological assessments

          8. Able and willing to undergo magneti resonance imaging (MRI) with contrast and computed
             tomography (CT)

          9. 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

         10. Subjects must have had physical therapy prior to entry (and be willing to continue to
             the extent possible)

         11. 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

         12. Ability of patient or legal authorized representative to understand and sign an
             Informed Consent

        Exclusion Criteria:

          1. History or presence of any other major neurological disease other than stroke

          2. Cerebral infarct size >150 cm3 measured by MRI

          3. Primary intracerebral hemorrhage

          4. Myocardial infarction within prior 6 mos.

          5. Malignancy unless in remission >5 yrs.

          6. Clinically significant finding on MRI of brain not related to stroke

          7. Any seizures in the 3 months prior to Screening

          8. More than 5 degrees of contracture at shoulder, elbow, wrist, fingers, hip, knee and
             ankle

          9. Other neurologic, neuromuscular or orthopedic disease that limits motor function

         10. Uncontrolled systemic illness, including, but not limited to: hypertension; diabetes;
             renal, hepatic, or cardiac failure

         11. Positive findings on tests for occult malignancy, unless a non-malignant etiology is
             confirmed

         12. Uncontrolled major psychiatric illness, including depression symptoms (CESD R Scale of
             ≥16 is exclusionary)

         13. Total bilirubin >1.9 mg/dL at Screening

         14. Serum creatinine >1.5 mg/dL at Screening

         15. Hemoglobin <10.0 g/dL at Screening

         16. Absolute neutrophil count <2000 /mm3 at Screening

         17. Absolute lymphocytes <800 /mm3 at Screening

         18. Platelet count <100,000 /mm3 at Screening

         19. Liver disease supported by AST (SGOT) or ALT (SGPT) ≥2.5 x upper limit of normal at
             Screening

         20. Serum calcium >11.5 mg/dL at Screening

         21. 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

         22. Presence of craniectomy or other contraindication to stereotactic surgery

         23. Participation in any other investigational trial within 4 weeks of initial screening
             and within 7 weeks of Baseline visit

         24. 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

         25. Substance use disorder (per DSM-V criteria, including drug or alcohol)

         26. Contraindications to head MRI (with constrast) or CT

         27. Pregnant or lactating

         28. Female patients of childbearing potential unwilling to use an adequate birth control
             method during the 12 months of the study

         29. 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

         30. Any prior SB623 cell implantation and/or any prior stem cell treatment for stroke or
             other reason regardless of mode of administration