Investigation of Neural Stem Cells in Ischemic Stroke

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Ischemic Stroke, Chronic Stroke, Hemiparesis, Arm Paralysis

In brief

A study of stereotactic, intracerebral injection of CTX0E03 neural stem cells into patients with moderate to moderately severe disability as a result of an ischemic stroke.

Key facts

Study ID

NCT03629275

Run by

ReNeuron Limited

People needed

15

Starts

2018-08-31

Expected to finish

2021-03-02

Last updated by the study team

2021-08-13

Who can join

Age: 35 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Ischemic stroke that includes the supratentorial region as confirmed by CT or MRI, occurring within 6 to 24 months of the time that surgical intervention will be performed (Qualifying Stroke Event)
• Modified Rankin Score of 3 or 4 due to the Qualifying Stroke Event
• Some residual upper limb movement
• Sufficient cognitive and language abilities to comprehend verbal commands and to carry out the study assessments
• No medical conditions that would preclude neurosurgery with appropriate preparation and management.
• Ability to attend study visits and complete all study assessments including ability to provide informed consent

You may not qualify if…

• Modified Rankin Score of >1 prior to the Qualifying Stroke Event
• Stroke due to hemorrhage or stroke known or suspected of being caused by, or related to, connective tissue disorder, congenital disorder of the cerebral vessels or a disorder of thrombosis; patients with atrial fibrillation as a suspected cause of stroke are NOT excluded
• Neurosurgical pathway obstructed by vascular malformation or cavity
• History of neurological or other disease resulting in significant functional impairment (e.g. Parkinson's disease, motor neuron disease, moderate dementia, arthritis, contractures or fixed anatomical abnormality)
• Inability to stop or transition off valproic acid or other demethylating agents or Histone deacetylases (HDAC) inhibitors for 1 week before and 4 weeks after surgery
• Use of selective serotonin reuptake inhibitors (SSRI), unless the subject is on a stable dose that has been started at least 2-months before screening (V1)
• Use of antispasticity medications (excluding oral antispasticity medications if they have been taken regularly for at least one month prior to surgery)The use of Botox® or similar is allowed if the last dose was ≥3 months prior to screening; however, its use will be prohibited until following the 12 month visit
• Inability to discontinue anticoagulation therapy for a required interval
• History of malignant disease within the last 5 years, or any history of primary or secondary brain malignant disease
• Patients who have previously participated in a cell-based therapy study at any time or in any other study involving an investigational product or rehabilitation study within the last 30 days
• Patients with clinically significant lab values, including positive Class I human leukocyte antigen (HLA) antibodies specific for CTX0E03
• Planned initiation of any new PT regimen within 6-months of surgery

Where it is running

• University of Arkansas — Little Rock, Arkansas, United States
• University of California, Irvine — Irvine, California, United States
• University of California, Los Angeles — Los Angeles, California, United States
• University of Southern California Neurorestoration Center — Los Angeles, California, United States
• Stanford University — Palo Alto, California, United States
• University of California, San Diego — San Diego, California, United States
• University of Miami — Coral Gables, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Emory — Atlanta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• Shirley Ryan Ability Lab — Chicago, Illinois, United States
• MedStar Health Research Institute — Hyattsville, Maryland, United States
• Henry Ford Health System — Detroit, Michigan, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• JFK Neuroscience Institute — Edison, New Jersey, United States
• Albany Medical College — Albany, New York, United States
• Duke University School of Medicine — Durham, North Carolina, United States
• Oregon Health and Science University — Portland, Oregon, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Chattanooga Center for Neurologic Research — Chattanooga, Tennessee, United States
• University of Texas Health Science Center — Houston, Texas, United States
• University of Texas Health Science Center — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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