Table 2.
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 |
aWe will measure the degree of involvement of the ipsilateral subventricular zone on the initial diffusion-weighted image at two axial levels; (a) the upper thalamus and head of caudate nucleus and (b) the corona radiate (7-mm upper level).
DWI diffusion-weighted image, HBV hepatitis B virus, HCV hepatitis C virus, hCG human chorionic gonadotropin, MCA middle cerebral artery.