Summary

Eligibility
for people ages 35-75 (full criteria)
Location
at Irvine, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

A Randomized, Placebo-Controlled Study of the Efficacy and Safety of Intracerebral Stem Cells (CTX0E03) in Subjects With Disability Following an Ischemic Stroke

Details

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.

Keywords

Ischemic Stroke Chronic Stroke Hemiparesis Arm Paralysis Efficacy Neural Stem cells Intracerebral Cerebral Infarction Cerebrovascular disorders Brain diseases Stereotactic surgery Stroke Paralysis Paresis Ischemia CTX0E03 Drug Product and delivery device

Eligibility

You can join if…

Open to people ages 35-75

  • 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 CAN'T join 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

Locations

  • University of California, Irvine
    Irvine California 92697 United States
  • University of California, Los Angeles
    Los Angeles California 90095 United States
  • University of Southern California Neurorestoration Center
    Los Angeles California 90095 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
ReNeuron Limited
ID
NCT03629275
Phase
Phase 2
Study Type
Interventional
Last Updated