Study to Determine The Effect of a Drug Called Neupogen on Stroke Recovery (GIST)

This is an interventional treatment trial for Ischemic Stroke focused on measuring Stroke, GCSF, Hematopoeitic, Neupogen, Filgrastim Read More

Inclusion Criteria:

• Patient is between 45 and 85 years of age
• Patient is of either gender
• The qualifying stroke is ischemic with a total NIH Stroke Score less than 18.
• The stroke involves the non-dominant hemisphere including the cerebral cortex and results in hemiparesis. The inclusion of sub-cortical strokes will be permitted if the size is of 3 cm or greater. Patients suffering strokes involving the dominant hemisphere resulting in mild dysphasia are also eligible.
• The stroke is classified as a partial anterior cerebral syndrome by the Oxfordshire Criteria.

• NIHSS at baseline evaluation with:

  *Level of consciousness is not impaired as defined by an NIHSS between 0 and 1 on question 1a and

• Hemiparesis as defined by

  • an NIHSS between 1 and 4 on questions 5 and/or
  • an NIHSS between 1 and 4 on questions 6.
• Be able to start the experimental treatment a minimum of 3 days and a maximum of 10 days after the initial presentation with the stroke,
• Patient or surrogate gives informed consent,
• The patient is fluent in either French or English.

Exclusion Criteria:

• Patient with hemorrhagic stroke,
• Patients with a pre-morbid modified Rankin score > 2 (Appendix 3b),
• Patients with pre-morbid dementia by DSM-IV criteria.
• Patients with a known allergic reaction to G-CSF or a component of G-CSF.

• Patients with one or more significant co-morbidities expected to limit lifespan to less than 12 months. Examples include but are not limited to:

  • > CHF Class II NYHA
  • Known prior or ongoing malignancy except non-melanomatous skin cancer.
  • Acute or chronic infections (HIV, TB, etc.. )
  • Other significant cardiac, renal, hepatic or pulmonary dysfunction.

• Patients with organ dysfunction that would preclude tests required for this study. Examples include but are not limited to:

  *Serum Cr > 200 μmol/L that would prevent administration of contrast dye.

• Patients with a known history of bone marrow dysfunction, such as myeloid leukemia or myeloproliferative state that would prevent treatment with G-CSF.

• Patients with metal implants that would preclude MRI examination including but not limited to patients with

  • pacemakers,
  • ear implants, and
  • aneurysm brain clips.

• Patients with:

  • a history compatible with a thrombophilic state or
  • with a pre-existing known thrombophilic state.
• Patient unwilling or unable to comply with trial requirements.
• Patients with an ongoing history of illicit drug use.
• Female patients of child-bearing potential.
• Patients exposed to other investigational drugs in the last 3 months.
• Patients with known or suspected sickle cell disease,
• Patients with splenic enlargement or an illness that results in splenic enlargement (For example, but not limited to myeloproliferative syndromes, hairy cell leukaemia, malaria, hepatic cirrhosis…),
• Patients with an ongoing history of alcohol abuse,
• Patients with a known or suspected history of allergy to intravenous contrast agents used for CT scans,
• Patients that have received a chemotherapy agent within the previous 5 years (For example, but not limited to cyclophosphamide, anthracycline, methotrexate, fluorouracil…)
• Patients that have received a therapy within the previous 5 years that interferes with hematopoiesis or circulating blood cells (For example, but not limited to Lithium, Campath….)
• Patients that have received a cytokine within the last 6 months or are currently receiving a cytokine treatment (For example, but not limited to Erythropoietin, Granulocyte Macrophage Colony Stimulating Factor, Keratinocyte Growth Factor, Kit Ligand…)