Intracerebral Transplantation of Neural Stem Cells for the Treatment of Ischemic Stroke
NCT ID: NCT03296618
Last Updated: 2017-10-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
18 participants
INTERVENTIONAL
2012-06-30
2018-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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NSI-566 neural stem cell implantation
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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
30 Years
65 Years
ALL
No
Sponsors
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Suzhou Neuralstem Biopharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Xu Ruxiang, M.D
Role: PRINCIPAL_INVESTIGATOR
BaYi Brain Hospital, Army General Hospital
Locations
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Ba Yi Brain Hospital
Beijing, , China
Countries
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References
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Glass JD, Boulis NM, Johe K, Rutkove SB, Federici T, Polak M, Kelly C, Feldman EL. Lumbar intraspinal injection of neural stem cells in patients with amyotrophic lateral sclerosis: results of a phase I trial in 12 patients. Stem Cells. 2012 Jun;30(6):1144-51. doi: 10.1002/stem.1079.
Boulis NM, Federici T, Glass JD, Lunn JS, Sakowski SA, Feldman EL. Translational stem cell therapy for amyotrophic lateral sclerosis. Nat Rev Neurol. 2011 Dec 13;8(3):172-6. doi: 10.1038/nrneurol.2011.191.
Lunn JS, Sakowski SA, Hur J, Feldman EL. Stem cell technology for neurodegenerative diseases. Ann Neurol. 2011 Sep;70(3):353-61. doi: 10.1002/ana.22487.
Lunn JS, Sakowski SA, Federici T, Glass JD, Boulis NM, Feldman EL. Stem cell technology for the study and treatment of motor neuron diseases. Regen Med. 2011 Mar;6(2):201-13. doi: 10.2217/rme.11.6.
Other Identifiers
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NS2012-1
Identifier Type: -
Identifier Source: org_study_id