Ischemic StrokePhase 1GISTNCT00809549
Study to Determine The Effect of a Drug Called Neupogen on Stroke Recovery
A Phase 1 study testing Filgrastim in people with Ischemic Stroke, run by Ottawa Hospital Research Institute at 2 sites in Canada.
Trial summary
1. Circulating bone marrow and blood vessel precursors home in to sites of ischemia and aid regeneration of injured tissue 2. Increasing the number of circulating precursors will improve in regeneration of damaged brain following ischemic stroke. Read more about this study
- Who is it for?
- Ages 45 to 85 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Filgrastim
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesCanada
- Study dates
- Jul 2006to Apr 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
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- 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…)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: Granulocyte-Colony Stimulating Factor In Ischemic Stroke (GIST): A Pilot Study
- Circulating bone marrow and blood vessel precursors home in to sites of ischemia and aid regeneration of injured tissue
- Increasing the number of circulating precursors will improve in regeneration of damaged brain following ischemic stroke.
Read the detailed description
We hypothesize that mobilization of bone marrow precursor cells into the blood stream will allow them to redistribute in the injured central nervous system and aid regeneration of damaged tissue. If the hypotheses is correct, it predicts that G-CSF treatment will improve the functional outcome of patients following acute ischemic stroke.
Underlying this work are the following considerations:
- Currently the clinical and functional outcomes following ischemic strokes are poor and require new treatment strategies.
- G-CSF administration is a well established routine treatment for the mobilization of hematopoietic and endothelial precursors from the bone marrow into the circulation.
- Acute ischemia locally increases factors that direct circulating bone marrow derived cells to home to these sites of injury.
- Evidence exists that bone marrow derived cells are able to repopulate different tissues including those of the CNS.
- Acute ischemic injury to the central nervous system provides a milieu for the regeneration of neural tissue.
- Conditions
- Ischemic Stroke
- Being tested
- Filgrastim
- Keywords
- Stroke, GCSF, Hematopoeitic, Neupogen, Filgrastim
- Medical subject headings
- Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgrastimDrug
Also called Brand Name: Neupogen, rhG-CSF
10 ug/kg sc once daily x 4 days. Repeated once, 6 weeks later.
| Study group | Role | What they receive |
|---|---|---|
| Normal Saline | Placebo comparator | Not described Receives: Drug: Filgrastim |
| Filgrastim | Experimental | Not described Receives: Drug: Filgrastim |
What is being measured
The primary outcome is the main question the study is designed to answer.
A statistically significant increase in: mortality/ non-fatal grade III or greater adverse events measured by the NCI Common Toxicity Scale/ incidence of recurrent strokes/ worsening of neurological disabilities measured by standardized stroke scales.
Measured: 6 weeks, 3 months, 6 months and 12 months after the first dose of the study drug.
Secondary outcomes (1)
The secondary endpoints address the feasibility and efficacy of the study treatment: adequacy of bone marrow cell mobilization/ validation of imaging sequences/ Identification of optimal parameters for follow-up to be used in a subsequent larger trial.
Measured: 6 weeks, 3 months, 6 months and 12 months after the first dose of the study drug.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startJul 2006
- Primary completionApr 2013 (estimated)
- Study completionApr 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Sharma, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809549
- Sponsor's protocol ID
- 2006076-01H
- Acronym
- GIST
- Status last verified
- Jul 2012
- First submitted
- 17 Oct 2008
- Last updated
- 13 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Granulocyte-Colony Stimulating Factor In Ischemic Stroke (GIST): A Pilot Study
- ClinicalTrials.gov ID
- NCT00809549
- Acronym / sponsor ID
- GIST / 2006076-01H
- Conditions
- Ischemic Stroke
- Keywords
- Stroke, GCSF, Hematopoeitic, Neupogen, Filgrastim
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Apr 2013 (estimated)
- Study completion
- Apr 2013 (estimated)
- First posted
- 17 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- Circulating bone marrow and blood vessel precursors home in to sites of ischemia and aid regeneration of injured tissue
- Increasing the number of circulating precursors will improve in regeneration of damaged brain following ischemic stroke.
Detailed description
We hypothesize that mobilization of bone marrow precursor cells into the blood stream will allow them to redistribute in the injured central nervous system and aid regeneration of damaged tissue. If the hypotheses is correct, it predicts that G-CSF treatment will improve the functional outcome of patients following acute ischemic stroke.
Underlying this work are the following considerations:
- Currently the clinical and functional outcomes following ischemic strokes are poor and require new treatment strategies.
- G-CSF administration is a well established routine treatment for the mobilization of hematopoietic and endothelial precursors from the bone marrow into the circulation.
- Acute ischemia locally increases factors that direct circulating bone marrow derived cells to home to these sites of injury.
- Evidence exists that bone marrow derived cells are able to repopulate different tissues including those of the CNS.
- Acute ischemic injury to the central nervous system provides a milieu for the regeneration of neural tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Saline | Placebo comparator | Drug: Filgrastim |
| Filgrastim | Experimental | Drug: Filgrastim |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (30 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilgrastimAlso: Brand Name: Neupogen, rhG-CSF10 ug/kg sc once daily x 4 days. Repeated once, 6 weeks later. | Drug | Filgrastim, Normal Saline |
Primary outcome
A statistically significant increase in: mortality/ non-fatal grade III or greater adverse events measured by the NCI Common Toxicity Scale/ incidence of recurrent strokes/ worsening of neurological disabilities measured by standardized stroke scales.
Time frame: 6 weeks, 3 months, 6 months and 12 months after the first dose of the study drug.
1 secondary outcome
The secondary endpoints address the feasibility and efficacy of the study treatment: adequacy of bone marrow cell mobilization/ validation of imaging sequences/ Identification of optimal parameters for follow-up to be used in a subsequent larger trial.
Time frame: 6 weeks, 3 months, 6 months and 12 months after the first dose of the study drug.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Sharma, MD principal investigator
The Ottawa Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Filgrastim in people with Ischemic Stroke, run by Ottawa Hospital Research Institute at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A statistically significant increase in: mortality/ non-fatal grade III or greater adverse events measured by the NCI Common Toxicity Scale/ incidence of recurrent strokes/ worsening of neurological disabilities measured by standardized stroke scales. (time frame: 6 weeks, 3 months, 6 months and 12 months after the first dose of the study drug.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2012.