Ischaemic and Haemorrhagic Stroke MedDRA version: 8.1 Level: LLT Classification code 10042244 Term: Stroke
Conditions
Interventions
Trade Name: Neupogen
Pharmaceutical Form: Concentrate for solution for injection
Pharmaceutical form of the placebo: Solution for injection
Route of adm
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Clinical stroke (lacunar or cortical); ischaemic or haemorrhagic type on neuro-imaging 3-30 days post-onset; arm and/or leg weakness (Scandinavian Stroke Scale, SSS arm and/or leg motor power =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Pre-morbid dependency, modified Rankin scale (mRS) >3; dementia; coma (SSS consciousness <4); malignancy; sickle cell disease; pregnancy; congenital neutropaenia; secondary acute myeloid leukaemia; known contra-indication to MRI in those with ischaemic stroke.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To further assess (in the context of STEMS1) the safety of G-CSF. ; Secondary Objective: i. To further assess the feasibility of administration and tolerance of G-CSF. ii. To assess the efficacy of G-CSF on stroke lesion size. iii. To study potential mechanisms of action by which G-CSF might improve outcome after stroke, with an emphasis on its effects on bone marrow derived PBSCs and their fate in the brain. iv. To assess the effects of G-CSF on haemostatic function1 and a surrogate marker of efficacy, Serum s-100 protien. v. To obtain information on functional outcome for use in the design of future trials ; Primary end point(s): PRIMARY –Number of patients having a serious adverse event by day 90. SECONDARY -Laboratory measures: During/post treatment (days 5, 10): CD34+ count; full blood count; soluble platelet function (P-selectin); coagulation factors (factor VIII, fibrinogen, von Willebrand factor).1, Clinical efficacy: (Days 10,90): Impairment (SSS, grip strength); dead or dependent (modified Rankin Scale (mRS)>2); dead or disabled (Barthel Index(BI)5 points); symptomatic intracranial haemorrhage; major extracranial haemorrhage. Safety, long-term follow-up: All patients will be ‘flagged’ with the Office for National Statistics to track death (and its cause) over the next 10 years). [Therapeutic clonal expansion of endogenous stem cells could, in theory, lead to malignancy and this will be monitored long-term (although this problem has not been observed to date with G-CSF in normal donors).] Feasibility: proportion of patients receiving all 5 G-CSF/placebo injections Post-mortem examination: Patients who die (and where prior declaration of intent was obtained pre-mortem from the patient and/or next-of-kin; and next-of-kin assent was obtained post-mortem) will | — |
Countries
United Kingdom
Outcome results
None listed