Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke
Trial ID or NCT#
Status
Purpose
Controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from ischemic stroke
Official Title
A Double-Blind, Controlled Phase 2b Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke
Eligibility Criteria
- 1. Age 18-75 years, inclusive2. Documented history of completed ischemic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement, with correlated findings by MRI3. Between 6 and 90 months (7.5 years) post-stroke, and having a chronic motor neurological deficit4. Neurological motor deficit substantially due to incident stroke5. Modified Rankin Score of 2-46. Require Motricity Index 30-75 (UE Scale) or 27-74 (LE Scale)7. Able to undergo all planned neurological assessments8. 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-start10. 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 possible12. Ability of patient or legal authorized representative to understand and sign an Informed Consent
- 1. History or presence of any other major neurological disease other than stroke2. Cerebral infarct size \>150 cm3 measured by MRI3. Primary intracerebral hemorrhage4. Myocardial infarction within prior 6 mos.5. Malignancy unless in remission \>5 yrs.6. Clinically significant finding on MRI of brain not related to stroke7. Any seizures in the 3 months prior to Screening8. More than 5 degrees of contracture at shoulder, elbow, wrist, fingers, hip, knee and ankle9. Other neurologic, neuromuscular or orthopedic disease that limits motor function10. Uncontrolled systemic illness, including, but not limited to: hypertension; diabetes; renal, hepatic, or cardiac failure11. Positive findings on tests for occult malignancy, unless a non-malignant etiology is confirmed12. Uncontrolled major psychiatric illness, including depression symptoms (CESD R Scale of ≥16 is exclusionary)13. Total bilirubin \>1.9 mg/dL at Screening14. Serum creatinine \>1.5 mg/dL at Screening15. Hemoglobin \<10.0 g/dL at Screening16. Absolute neutrophil count \<2000 /mm3 at Screening17. Absolute lymphocytes \<800 /mm3 at Screening18. Platelet count \<100,000 /mm3 at Screening19. Liver disease supported by AST (SGOT) or ALT (SGPT) ≥2.5 x upper limit of normal at Screening20. Serum calcium \>11.5 mg/dL at Screening21. 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 surgery22. Presence of craniectomy or other contraindication to stereotactic surgery23. Participation in any other investigational trial within 4 weeks of initial screening and within 7 weeks of Baseline visit24. Botulinum toxin injection, phenol injection, intrathecal baclofen, or any other interventional treatments for spasticity (except bracing and splinting) 16 weeks prior to the Baseline visit25. Substance use disorder (per DSM-V criteria, including drug or alcohol)26. Contraindications to head MRI (with constrast) or CT27. Pregnant or lactating28. Female patients of childbearing potential unwilling to use an adequate birth control method during the 12 months of the study29. Any other condition or situation that the investigator believes may interfere with the safety of the subject or the intent and conduct of the study30. Any prior SB623 cell implantation and/or any prior stem cell treatment for stroke or other reason regardless of mode of administration
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Contact
Guiping Qin
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