- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03296618
Intracerebral Transplantation of Neural Stem Cells for the Treatment of Ischemic Stroke
October 3, 2017 updated by: Suzhou Neuralstem Biopharmaceuticals
Phase I Clinical Study of Intracerebral Transplantation of Neural Stem Cells for the Treatment of Ischemic Stroke
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.
Study Overview
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
Enrollment (Anticipated)
18
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Beijing, China
- Ba Yi Brain Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
- Men and women 30-65 years old
- 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)
- At least 3 months but no more than 24 months from time of stroke, with a motor neurological deficit
- Documented history of completed ischemic stroke in subcortical region of MCA or lenticulostriate artery with or without cortical involvement, with correlated findings by MRI
- Modified Rankin Score of 2, 3 or 4
- FMMS score of 55 or less;
- Two evaluations at approximately 3 weeks apart prior to surgery with less than +/- 4 point change in the NIHSS
- Able and willing to meet all follow-up requirements
- Able and willing to undergo post-physical therapy/rehabilitation
Exclusion Criteria:
- Any disabling psychological or psychiatric disorders which may confound the study
- History of more than one symptomatic stroke, TIAs allowed
- History of another major neurological disease or injury
- Cerebral infarct size >8cm in any one measurement
- Myocardial infarction within the prior 3 months
- History of seizures or current use of antiepileptic medication
- Receipt of any investigational drug or device within 30 days
- Receipt of any cell infusion other than blood transfusion
Any concomitant medical disease or condition noted below:
- Coagulopathy with INR > 1.4 at the time of surgery
- Panel Reactive Antibodies (PRA) > 20% at initial screen
- Active infection at the time of surgery
- Active hypotension requiring vasopressor therapy
- Skin breakdown over the site of surgery
- Active or history of malignancy
- Primary or secondary immune deficiency
- Persistent MRI artifact that would prevent imaging pre and post-operation or unable to undergo MRI
- 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)
Presence of any of the following conditions:
- Current drug abuse or alcoholism
- Unstable medical conditions
- Unstable psychiatric illness including psychosis and untreated major depression
- Any condition that the Investigator or primary physician feels may interfere with participation in the study or may endanger the subject
- Any condition that the surgeon feels may pose complications for the surgery
- Known hypersensitivity to tacrolimus or methylprednisolone
- Unable or unwilling to participate in physical and/or occupational therapy or return to clinic for follow up examinations as scheduled
- Inability to provide informed consent as determined by screening protocol.
- Use of antiplatelet drugs less than 2 weeks before surgery
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: NSI-566 neural stem cell implantation
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse Events
Time Frame: 24 months
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24 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical improvement using NIH Stroke Scale
Time Frame: 12 months
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12 months
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Clinical improvement using Modified Rankin Scale
Time Frame: 12 months
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12 months
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Clinical improvement using Fugl-Meyer Motor Score
Time Frame: 12 months
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12 months
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Clinical Improvement using Mini-mental State Examination
Time Frame: 12 months
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12 months
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Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MRI analysis of transplant site
Time Frame: 12 months
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12 months
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PET analysis of transplant site
Time Frame: 12 months
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12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Xu Ruxiang, M.D, BaYi Brain Hospital, Army General Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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, 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. Erratum In: Regen Med. 2011 Jul;6(4):536.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (ANTICIPATED)
May 1, 2018
Study Completion (ANTICIPATED)
May 1, 2018
Study Registration Dates
First Submitted
September 22, 2017
First Submitted That Met QC Criteria
September 25, 2017
First Posted (ACTUAL)
September 28, 2017
Study Record Updates
Last Update Posted (ACTUAL)
October 5, 2017
Last Update Submitted That Met QC Criteria
October 3, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NS2012-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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