A Safety and Tolerability Study of 42037788 (Referred to as CNTO 0007) Compared With Placebo in Patients Who Have Experienced Ischemic Cerebral Infarction (Also Known as Stroke)

This is a first-in-human (FIH) study of 42037788 (referred to as CNTO 0007), a cell therapy
being tested to see if it may be useful in treating patients with ischemic cerebral
infarction also known as stroke. Patients will be randomized (assigned by chance) to receive
a single dose of CNTO 0007 or placebo (identical in appearance to CNTO 0007 but does not
contain cells) by intravenous (IV) infusion (injection directly into a vein). Patients and
study staff will not know if patients are assigned CNTO 0007 or the placebo. The study will
be conducted in 2 stages (Stage A and Stage B). In Stage A, the highest dose of CNTO 0007
that does not cause unacceptable side effects, referred to as the maximum tolerated dose
(MTD) will be determined to and administered to patients in Stage B of the study. In Stage
A, 5 (up to 7) cohorts (groups) of 4-8 patients each will be administered a single IV
infusion of CNTO 0007 or placebo 1-5 days (depending on cohort) after stroke (the first
cohort of patients will receive the lowest dose of CNTO 0007 or placebo and each subsequent
cohort will be administered a higher dose of CNTO 0007 or placebo until the MTD is
determined). In Stage B, patients will be administered a single IV infusion of the MTD
within a specified number of days after stroke.