Therapeutic Candidate or Device
A cell therapy that delivers high levels of neurotrophic factors to the CNS
Indication
Amyotrophic lateral sclerosis (ALS) or Lou Gehrig Disease
Therapeutic Mechanism
The Cell therapy is aimed at providing high levels of neurotrophic factors directly to the CNS, to support the dying neurons
Unmet Medical Need
Amyotrophic lateral sclerosis (ALS) is a fatal neurological disease in which the degeneration and death of motor neurons (MNs) leads to weakness, paralysis and eventually respiratory failure . There remains a great unmet medical need for safe and effective treatments for people with ALS.
Project Objective
Phase 3 completed
Major Proposed Activities
- Manufacturing of cell therapy product
- Enrolling 200 patients for the study
- Run clinical trial
Manufacturing of the cell therapy product for all US medical centers participating in the study will be exclusively in California
The study will include 2 clinical sites in California that will enroll 80 Californian patients of the the total 200 patients in the study.