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Table 2 Inclusion and exclusion criteria

From: Intravenous transplantation of mesenchymal stem cells preconditioned with early phase stroke serum: current evidence and study protocol for a randomized trial

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
  1. 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).
  2. DWI diffusion-weighted image, HBV hepatitis B virus, HCV hepatitis C virus, hCG human chorionic gonadotropin, MCA middle cerebral artery.