International study of MultiStem cell therapy for ischemic stroke
Phase of Trial: Phase III
Latest Information Update: 08 Aug 2017
At a glance
- Drugs Allogeneic stem cell therapy Athersys (Primary)
- Indications Stroke
- Focus Registrational; Therapeutic Use
- Acronyms MASTERS-2
- Sponsors Athersys
- 08 Aug 2017 According to an Athersys media release, design of this trial has received a Final Scientific Advice positive opinion from the European Medicines Agency. Also US FDA has granted Fast Track Designation for Multistem.
- 28 Sep 2016 According to an Athersys media release, this trial is expected to initiate in 2017.
- 28 Sep 2016 According to an Athersys media release, the company has received agreement from the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design and planned analysis of this trial. The data from the trial would provide the foundation of the regulatory package to be submitted for marketing approval.