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

Active, not recruiting

Phase 1 Results N/A

Update History

14 Jul '12
A location was updated in Ottawa.
New
The overall status was removed for The Ottawa Hospital.
A location was updated in Toronto.
New
The overall status was removed for Sunnybrook Health Sciences Centre.
6 Oct '11
The eligibility criteria were updated.
New
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…)
Old
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 ?mol/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…)