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

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ClinicalTrials.gov Identifier: NCT03296618
Recruitment Status : Active, not recruiting
First Posted : September 28, 2017
Last Update Posted : October 5, 2017
Sponsor:
Information provided by (Responsible Party):
Neuralstem Inc. ( Suzhou Neuralstem Biopharmaceuticals )

Brief 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.

Condition or disease Intervention/treatment Phase
Ischemic Motor Stroke, Chronic Drug: NSI-566 Phase 1

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I Clinical Study of Intracerebral Transplantation of Neural Stem Cells for the Treatment of Ischemic Stroke
Study Start Date : June 2012
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Arm Intervention/treatment
Experimental: NSI-566 neural stem cell implantation Drug: NSI-566
Dosing will consist of a one-time stereotactic, intracranial injection of a hNSC line, NSI-566, ranging from 1.2×107 cells to 8×107 cells, as tolerated.




Primary Outcome Measures :
  1. Adverse Events [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Clinical improvement using NIH Stroke Scale [ Time Frame: 12 months ]
  2. Clinical improvement using Modified Rankin Scale [ Time Frame: 12 months ]
  3. Clinical improvement using Fugl-Meyer Motor Score [ Time Frame: 12 months ]
  4. Clinical Improvement using Mini-mental State Examination [ Time Frame: 12 months ]

Other Outcome Measures:
  1. MRI analysis of transplant site [ Time Frame: 12 months ]
  2. PET analysis of transplant site [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Have the ability to understand the requirements of the study, provide written informed consent, understand and provide written authorization for the use and disclosure of Protected Health Information (PHI) [per Health Insurance Portability and Accountability 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 of contraception or be of non-childbearing potential (post-menopausal for at least 2 years 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 motor neurological deficit
  5. Documented history of completed ischemic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement, with correlated findings by 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 +/- 4 point 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 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:

    1. Coagulopathy with INR > 1.4 at the time of surgery
    2. Panel Reactive Antibodies (PRA) > 20% at initial screen
    3. Active infection at the time of surgery
    4. Active hypotension requiring vasopressor therapy
    5. Skin breakdown over the site of surgery
    6. Active or history of malignancy
    7. Primary or secondary immune deficiency
    8. Persistent MRI artifact that would prevent imaging pre and post-operation or unable to undergo MRI
    9. Creatinine >115μmol/L, liver function tests (SGOT/SGPT, Bilirubin, Alk Phos) > 2x upper 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 hemoglobin A1C>8%), evidence of GI bleeding by hemoccult test,positive tuberculosis (TB test: PPD/Mantoux), hepatitis B or C, or human immunodeficiency virus (HIV)
  10. Presence of any of the following conditions:

    1. Current drug abuse or alcoholism
    2. Unstable medical conditions
    3. Unstable psychiatric illness including psychosis and untreated major depression
  11. Any condition that the Investigator or primary physician feels may interfere with participation in the study or may endanger the subject
  12. Any condition that the surgeon feels may pose complications for the surgery
  13. Known hypersensitivity to tacrolimus or methylprednisolone
  14. Unable or unwilling to participate in physical and/or occupational therapy or return to clinic for follow up examinations as scheduled
  15. Inability to provide informed consent as determined by screening protocol.
  16. Use of antiplatelet drugs less than 2 weeks before surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03296618


Locations
China
Ba Yi Brain Hospital
Beijing, China
Sponsors and Collaborators
Suzhou Neuralstem Biopharmaceuticals
Investigators
Principal Investigator: Xu Ruxiang, M.D BaYi Brain Hospital, Army General Hospital

Publications:
Responsible Party: Suzhou Neuralstem Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT03296618     History of Changes
Other Study ID Numbers: NS2012-1
First Posted: September 28, 2017    Key Record Dates
Last Update Posted: October 5, 2017
Last Verified: October 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Neuralstem Inc. ( Suzhou Neuralstem Biopharmaceuticals ):
chronic stroke
neural stem cell
transplant
paralysis

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes