Intracerebral Transplantation of Neural Stem Cells for the Treatment of Ischemic Stroke

Last updated: October 3, 2017
Sponsor: Suzhou Neuralstem Biopharmaceuticals
Overall Status: Trial Status Unknown

Phase

1

Condition

Stroke

Cerebral Ischemia

Occlusions

Treatment

N/A

Clinical Study ID

NCT03296618
NS2012-1
  • Ages 30-65
  • All Genders

Study Summary

The study is to determine the safety of human neural stem cell transplantation for the treatment of paralysis and related symptoms due to chronic motor stroke and to determine the maximum tolerated dose.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Have the ability to understand the requirements of the study, provide written informedconsent, understand and provide written authorization for the use and disclosure ofProtected Health Information (PHI) [per Health Insurance Portability andAccountability Act (HIPAA) Privacy Ruling] and comply with the study procedures

  2. Men and women 30-65 years old

  3. Women must have a negative serum pregnancy test and practice an acceptable method ofcontraception or be of non-childbearing potential (post-menopausal for at least 2years or who have undergone hysterectomy or oophorectomy or surgical sterilization)

  4. At least 3 months but no more than 24 months from time of stroke, with a motorneurological deficit

  5. Documented history of completed ischemic stroke in subcortical region of MCA orlenticulostriate artery with or without cortical involvement, with correlated findingsby MRI

  6. Modified Rankin Score of 2, 3 or 4

  7. FMMS score of 55 or less;

  8. Two evaluations at approximately 3 weeks apart prior to surgery with less than +/- 4point change in the NIHSS

  9. Able and willing to meet all follow-up requirements

  10. Able and willing to undergo post-physical therapy/rehabilitation

Exclusion

Exclusion Criteria:

  1. Any disabling psychological or psychiatric disorders which may confound the study

  2. History of more than one symptomatic stroke, TIAs allowed

  3. History of another major neurological disease or injury

  4. Cerebral infarct size >8cm in any one measurement

  5. Myocardial infarction within the prior 3 months

  6. History of seizures or current use of antiepileptic medication

  7. Receipt of any investigational drug or device within 30 days

  8. Receipt of any cell infusion other than blood transfusion

  9. Any concomitant medical disease or condition noted below:

  10. Coagulopathy with INR > 1.4 at the time of surgery

  11. Panel Reactive Antibodies (PRA) > 20% at initial screen

  12. Active infection at the time of surgery

  13. Active hypotension requiring vasopressor therapy

  14. Skin breakdown over the site of surgery

  15. Active or history of malignancy

  16. Primary or secondary immune deficiency

  17. Persistent MRI artifact that would prevent imaging pre and post-operation orunable to undergo MRI

  18. Creatinine >115μmol/L, liver function tests (SGOT/SGPT, Bilirubin, Alk Phos) > 2xupper limit of normal, hematocrit/hemoglobin < 30/10, total WBC < 4000/mm3,platelet count <100,000/mm3, uncontrolled hypertension (systolic > 180mmHg or diastolic> 100mmHg) or uncontrolled diabetes (defined as hemoglobinA1C>8%), evidence of GI bleeding by hemoccult test,positive tuberculosis (TBtest: PPD/Mantoux), hepatitis B or C, or human immunodeficiency virus (HIV)

  19. Presence of any of the following conditions:

  20. Current drug abuse or alcoholism

  21. Unstable medical conditions

  22. Unstable psychiatric illness including psychosis and untreated major depression

  23. Any condition that the Investigator or primary physician feels may interfere withparticipation in the study or may endanger the subject

  24. Any condition that the surgeon feels may pose complications for the surgery

  25. Known hypersensitivity to tacrolimus or methylprednisolone

  26. Unable or unwilling to participate in physical and/or occupational therapy or returnto clinic for follow up examinations as scheduled

  27. Inability to provide informed consent as determined by screening protocol.

  28. Use of antiplatelet drugs less than 2 weeks before surgery

Study Design

Total Participants: 18
Study Start date:
June 01, 2012
Estimated Completion Date:
May 31, 2018

Study Description

This is a Phase I study of human neural stem cell transplantation for the treatment of chronic motor stroke. This single-site, Phase I, open-label study may enroll up to 18 patients across 5 cohorts of ascending doses of human neural stem cells to define maximal tolerated dose.

Connect with a study center

  • Ba Yi Brain Hospital

    Beijing,
    China

    Site Not Available

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