- How well the investigational product (MultiStem®) works as a treatment to improve recovery from an ischemic stroke.
- How well-tolerated MultiStem® is when used as a treatment for ischemic stroke.
To determine how well MultiStem® works and how well tolerated it is, MultiStem® treatment will be compared to placebo. Placebo looks identical to MultiStem®, and is administered the same way, but it has no active ingredients.
Study participants must meet these criteria:
- 18 years of age or older
- Recently diagnosed with an ischemic stroke
- Stroke symptoms began less than 28 hours before entering the study
- Other participation criteria will need to be met
If you agree to participate and meet all eligibility criteria, you will:
- Be randomly assigned, with a 50% chance, to receive either MultiStem® or placebo. Neither you nor the study team will know to which treatment group you are assigned.
- Receive an IV infusion of MultiStem® or placebo within 36 hours after stroke.
- Participate in follow-up assessments, including questionnaires, laboratory tests, and physical exams.
After being discharged from the hospital, you will continue to be monitored in the study for about a year. This will include approximately 4 outpatient clinic visits at the hospital or study center as well as additional follow up by phone.
