Safety and Tolerability Study of Neural Stem Cells (NR1) in Subjects with Chronic Ischemic Subcortical Stroke
Grant Award Details
Grant Type:
Grant Number:
CLIN2-12379
Investigator(s):
Disease Focus:
Human Stem Cell Use:
Award Value:
$11,998,988
Status:
Active
Grant Application Details
Application Title:
Safety and Tolerability Study of Neural Stem Cells (NR1) in Subjects with Chronic Ischemic Subcortical Stroke
Public Abstract:
Therapeutic Candidate or Device
A human embryonic derived, non-genetically modified neural stem cell (NR1), originally derived from the Wi-Cell H-9 line
Indication
Patients with chronic motor deficits, from 6 to 60 months after stroke. NR1 cells will be injected into the brain near the site of the stroke.
Therapeutic Mechanism
The proposed therapeutic mechanism of action of NR1 neural stem cells is the secretion of factors that enhance the brain’s own ability to heal itself after stroke, including the creation of new blood vessels to replace those that were injured beyond repair, and modulation of the immune system.
Unmet Medical Need
Strokes are a leading cause of adult disability. There is no medical therapy able to promote recovery in chronic stroke patients, establishing stroke as a major unmet medical need. NR1 cells will be the first stem cell-derived therapy directed towards improving disability for this disease.
Project Objective
Complete a Phase 1 / Phase 2a trial with analysis
Major Proposed Activities
A human embryonic derived, non-genetically modified neural stem cell (NR1), originally derived from the Wi-Cell H-9 line
Indication
Patients with chronic motor deficits, from 6 to 60 months after stroke. NR1 cells will be injected into the brain near the site of the stroke.
Therapeutic Mechanism
The proposed therapeutic mechanism of action of NR1 neural stem cells is the secretion of factors that enhance the brain’s own ability to heal itself after stroke, including the creation of new blood vessels to replace those that were injured beyond repair, and modulation of the immune system.
Unmet Medical Need
Strokes are a leading cause of adult disability. There is no medical therapy able to promote recovery in chronic stroke patients, establishing stroke as a major unmet medical need. NR1 cells will be the first stem cell-derived therapy directed towards improving disability for this disease.
Project Objective
Complete a Phase 1 / Phase 2a trial with analysis
Major Proposed Activities
- Complete a Phase 1 / Phase 2a Clinical Trial for NR1 treatment after stroke and initial data analysis
- Manufacture a cGMP NR1 working cell bank and clinical lot
- Complete the potency assay and stability program development
Statement of Benefit to California:
This program provides several areas of benefit to California as the first stem cell-derived therapy for recovery of function after stroke. It will provide medical benefits by treating disabled Californians. It will provide an economic benefit as a medical therapy that is manufactured and tested within the state. It will provide scientific benefit by pioneering the science of brain repair in California universities, with likely spin-off of additional novel therapies for neurological disease.