Trial Search Results
Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke
Controlled study of stereotactic, intracranial injection of SB623 cells in patients with fixed motor deficits from ischemic stroke
Stanford is currently not accepting patients for this trial.
Lead Sponsor:
SanBio, Inc.
Collaborator: Sunovion
Stanford Investigator(s):
Intervention(s):
- Biological: SB623 Implant (2.5M)
- Biological: SB623 Implant (5.0M)
- Procedure: Sham surgery
Phase:
Phase 2
Eligibility
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
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study
All
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Not Recruiting