Safety of Escalating Doses of Intravenous Bone Marrow-Derived Mesenchymal Stem Cells in Patients With a New Ischemic Stroke

Inclusion Criteria:

- 1. Ischemic stroke in the middle cerebral artery territory, with onset 24-72 hours
prior to the time that the therapy transfusion is initiated, radiologically
confirmed, and with either diameter >15 mm or volume > 4cc.

- 2. The index stroke has clinical deficits that are moderate-severe (NIHSS score
7-20), did not require hemicraniectomy or invasive intracranial pressure monitoring,
and was not associated with a concomitant STelevation myocardial infarction.

- 3. Age 18-80 years, inclusive

- 4. Reasonable likelihood of receiving standard post-stroke medical care, as well as
standard physical, occupational, and speech therapy.

Exclusion Criteria:

- 1. No substantial pre-stroke disability (pre-stroke modified Rankin Scale score 0-2).

- 2. Females of child-bearing potential will be excluded unless (1) a negative urine
pregnancy test is obtained and (2) the patient has been effectively using
contraceptive method with known failure rate <1 % for at least 90 days.

- 3. Lactating mothers

- 4. If thrombolytic therapy has been administered, at least 24 hours have passed
between completing thrombolytic dosing and initiating the current study's
transfusion.

- 5. Known allergy to penicillin or to fetal bovine serum

- 6. Active co-existent major neurological or psychiatric disease that could
significantly interfere with patient compliance or study assessments, including drug
or alcohol abuse.

- 7. Any diagnosis that makes survival to 1-year post-stroke unlikely.

- 8. Participation in any other experimental therapeutic clinical trial concurrently or
in the prior three months.

- 9. Contraindication to undergoing MRI scanning.