MASTERS-2 Study

What is the purpose of the MASTERS-2 study?

The purpose of the MASTERS-2 study is to determine:

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• 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.

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Who can take part in the MASTERS-2 study?

Study participants must meet these criteria:

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• 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.