Allogeneic Mesenchymal Stem Cells for the Survivors of Ischemic Stroke Trial (ASSIST)

Inclusion Criteria:

• 18 years or older.
• Clinical diagnosis of ischemic stroke for more than 6 months.
• Imaging findings suggestive of ischemic stroke with functional deficits at initialdiagnosis and enrollment.
• Severe neurological impairment associated with the diagnosis of ischemic stroke thatresulted in the subject needing assistance to walk or not being able to performgeneral daily activities independently.
• No substantial improvement in neurologic or functional deficits for the 2 months priorto enrollment.
• NIHSS score between 6-20.
• Life expectancy longer than 12 months.
• Prior to treatment, the patient received standard medical care for secondaryprevention of ischemic stroke, including but not limited to appropriate blood pressureand cholesterol control measures, use of antiplatelet agents or anticoagulants (exceptwhen prohibited).
• Understand and provide signed informed consent, or have a designated legal guardian orspouse make such decision voluntarily on behalf of the subject.
• Expected that the patient will receive standard medical care for secondary preventionof ischemic stroke and participate in all planned safe follow-up visits reasonably.
• Organ function as defined by the following criteria: AST ≤ 2.5×ULN ALT ≤ 2.5×ULN TSB ≤1.5×ULN PT ≤1.25×ULN and PTT ≤1.25×ULN in subjects who didnot receive antithrombotic therapy Serum albumin ≥ 3.0g/dL ANC ≥ 1,500/μL Platelets ≥ 150,000/μL Hemoglobin ≥ 9.0g/dL Serum creatinine ≤ 1.5×ULN Serum amylase or lipase ≤ 1.0×ULN

Exclusion Criteria:

• History of epilepsy.
• History of cancer.
• History of brain trauma and brain tumor.
• Positive for hepatitis B surface antigen, E antigen, E antibody, core antibody,hepatitis C, HIV or RPR.
• Myocardial infarction occurred within six months of study entry.
• Any other medical problems of clinical significance, abnormal mental or test resultsthat the investigator or sponsor determined participating in the study pose a safetyrisk to the subject.
• Imaging findings suggestive of subarachnoid hemorrhage or intracerebral hemorrhage inthe past 12 months.
• Participation in any study of experimental drug or device within 3 months.
• Participation in other study related to stem cell-therapy.
• History of drug or alcohol abuse within 1 year.
• Pregnant, lactating or planning to become pregnant during the trial.
• Allergic to cattle or pork products.