MultiStem® is an investigational stem cell product designated by the United States Food and Drug Administration (FDA) as a Regenerative Medicine Advanced Therapy. Receiving MultiStem® cells is similar to getting a blood transfusion, except it is a cell product made by collecting cells from a healthy, young adult bone marrow donor.
An “investigational” product is a medication that is still being studied in clinical trials. MultiStem® has not been approved by the US Food and Drug Administration, the European Medicines Agency, or any other regulatory authority for treating patients outside of a clinical trial. MultiStem® cells are referred to as “investigational” because they are currently only approved for use in volunteers participating in a research study.
MultiStem® is given to patients via IV infusion and is designed for treatment of acute ischemic stroke within 36 hours after the start of symptoms. MultiStem® may increase blood flow to the damaged area of the brain, reduce inflammation in damaged tissue, and enhance tissue repair and healing in other ways.
Yes, there have been over 5 clinical research studies completed using MultiStem®. More than 200 participants have been administered single or multiple doses of MultiStem® cell therapy in these studies examining treatment of stroke and other diseases.