What is the purpose of the MASTERS-2 study?
The purpose of the MASTERS-2 study is to determine:
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.
Who can take part in the MASTERS-2 study?
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.
What will happen during the study?
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.
The patient journey outlines what study participants can expect during the MASTERS-2 study.