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


Phase 1/2 Results N/A

Eligibility Criteria

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.