No. | Criteria type |
---|---|
Inclusion | |
1 | Men or women (women must be of non-child-bearing potential), age 30 to 75 years |
2 | Stroke observed within 90 days of the onset of symptoms |
3 | Radiological: |
 | Relevant lesions within the MCA territory as assessed using DWI. |
 | Maximum diameter of the stroke region in any dimension ≥15 mm |
 | Damage not involving more than a half of the ipsilateral subventricular zonea |
4 | Clinical (National Institutes of Health Stroke Scale (NIHSS)): |
 | a. Moderate to severe persistent neurologic deficit (NIHSS of 6 to 21 inclusive) |
 | b. New onset of extremity paresis on the affected side, defined as a score of 2 to 4 on the NIHSS motor arm (item 5) or leg (item 6) question. |
 | c. Alert or drowsy but easily arousable as defined by score of 0 to 1 on the NIHSS level of consciousness question (item 1A). |
 | d. 'Slow recovery’ defined as change in NIHSS ≤1 point/3 days |
5 | Willingness: |
 | a. Reasonable likelihood of receiving standard physical, occupational and speech rehabilitation therapy as indicated for post-stroke deficits |
 | b. Able to participate in the evaluation process to the point of accurate assessment |
 | c. Willing and able to comply with scheduled visits, lifestyle guidelines, treatment plan, laboratory tests, and other study procedures |
 | d. Evidence of a personally signed and dated informed consent document |
6 | Use of antiplatelet, anticoagulant and/or antithrombotic agents is acceptable |
Exclusion | |
1 | Presence of significant disability prior to the current stroke, defined as pre-stroke modified Rankin score of 2 or more |
2 | Stroke that is either: |
 | a. Lacunar infarction |
 | b. Hematologic cause of stroke |
 | c. Recurrent or progressive stroke within 1 week at the time of screening |
3 | Hematologic disorders or bone marrow suppression |
4 | Severe medical illness defined as: |
 | a. Severe heart failure |
 | b. Severe febrile illness |
 | c. Hepatic or renal dysfunction |
 | d. Active cancer |
 | e. Any evidence of chronic comorbid condition or unstable acute systemic illnesses which, in the investigator’s opinion, could shorten survival or limit ability to complete the study |
5 | Presence of HIV, HBV, HCV, or syphilis on admission blood tests |
6 | Presence of active depression not adequately controlled that interferes with major activities of daily living immediately prior to the current stroke |
7 | Presence of dementia prior to the current stroke that is likely to confound clinical evaluation |
8 | Lactating women or pregnant women as determined by positive urine hCG test |
9 | Considered unwilling or unable to comply with the procedures and study visit schedule outlined in the protocol |
10 | Unwilling to undergo bone marrow aspiration |