Investigation of Neural Stem Cells in Ischemic Stroke

• Status: Terminated
• Trial end date: 2021-03-02
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ReNeuron Limited

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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