Investigation of Neural Stem Cells in Ischemic Stroke (PISCES III)

ReNeuron

Status and phase

Terminated

Phase 2

Conditions

Ischemic Stroke

Arm Paralysis

Hemiparesis

Chronic Stroke

Treatments

Drug: Placebo

Combination Product: CTX0E03 Drug Product and delivery device

Study type

Interventional

Funder types

Industry

Identifiers

NCT03629275

RN01-CP-0003

Details and patient eligibility

About

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.

Full description

This is a randomized, placebo-controlled, multi-center study. Patients with persistent disability 6-24 months following an ischemic stroke will be enrolled following confirmation of eligibility. Patients will be randomized 2:1 to undergo a stereotactic surgery and receive a single administration of CTX0E03 Drug Product by intracerebral implantation or undergo sham surgery only (placebo). Patients will be followed for 12 months after surgery with follow-up assessments occurring at various time points over the 12 months. All eligible patients will be assigned a standardized Physical Therapy (PT) program. Patients will complete their daily PT exercises at home for 12 weeks after their surgery.

Enrollment

15 patients

Sex

All

Ages

35 to 75 years old

Volunteers

No Healthy Volunteers

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