Phase I Clinical Study of Intracerebral Transplantation of Neural Stem Cells for the Treatment of Ischemic Stroke

Suzhou Neuralstem Biopharmaceuticals1 site in 1 country18 target enrollmentJune 2012

ConditionsIschemic Motor Stroke, Chronic

InterventionsNSI-566

DrugsNSI-566

Overview

Phase: Phase 1
Intervention: NSI-566
Conditions: Ischemic Motor Stroke, Chronic
Sponsor: Suzhou Neuralstem Biopharmaceuticals
Enrollment: 18
Locations: 1
Primary Endpoint: Adverse Events
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

May 2018

Last Updated

8 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Suzhou Neuralstem Biopharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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