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Ischemic Motor Stroke, ChronicPhase 1NCT03296618

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

A Phase 1 study testing NSI-566 in people with Ischemic Motor Stroke, Chronic, run by Suzhou Neuralstem Biopharmaceuticals at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 65 years
Conditions the study is for
Ischemic Motor Stroke, Chronic
What is being tested?
NSI-566
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
Jun 2012to May 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 10Show fewer
  • 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

Who cannot join

  • 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
Show all 28Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • Ba Yi Brain Hospital

    Beijing

Other trials in China

About this study

Official title: 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.

Read the 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.

Being tested
NSI-566
Keywords
chronic stroke, neural stem cell, transplant, paralysis
Medical subject headings
Bronchiolitis Obliterans Syndrome, Paralysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NSI-566Drug

    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.

Study groups in NCT03296618
Study groupRoleWhat they receive
NSI-566 neural stem cell implantationExperimentalNot described
Receives: Drug: NSI-566

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse Events

    Measured: 24 months

Secondary outcomes (4)

  1. Clinical improvement using NIH Stroke Scale

    Measured: 12 months

  2. Clinical improvement using Modified Rankin Scale

    Measured: 12 months

  3. Clinical improvement using Fugl-Meyer Motor Score

    Measured: 12 months

  4. Clinical Improvement using Mini-mental State Examination

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Sep 2017
  2. Study startJun 2012
  3. Primary completionMay 2018 (estimated)
  4. Study completionMay 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03296618
Sponsor's protocol ID
NS2012-1
Status last verified
Oct 2017
First submitted
22 Sep 2017
Last updated
5 Oct 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 22415942

  • 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.

    PubMed 22158518

  • 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.

    PubMed 21905078

  • 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.

    PubMed 21391854

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing NSI-566 in people with Ischemic Motor Stroke, Chronic, run by Suzhou Neuralstem Biopharmaceuticals at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse Events (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03296618, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2017.

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