Stroke (ischaemic) Circulatory System Stroke
Conditions
Interventions
Subcutaneous human recombinant G-CSF (filgrastim from Amgen) versus placebo.
G-CSF - 1 x 10^5 - 3 x 10^6 µ/kg given once or once daily for 5 days, in dosing blocks: 1 dose or 5 doses 1 x 10^5 µ/kg - 3
Sponsors
University of Nottingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Clinical stroke (lacunar or cortical) 2. 7 - 30 days post-onset 3. Arm and/or leg weakness (Scandinavian Stroke Scale [SSS], arm and/or leg motor power less than 6)
Exclusion criteria
Exclusion criteria: 1. Pre-morbid dependency, modified Rankin scale (mRS) greater than 3 2. Primary intracerebral haemorrhage 3. Dementia 4. Coma (SSS consciousness less than 4) 5. Malignancy 6. Sickle cell disease 7. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Circulating CD 34+ (flow cytometry) stem cells - aim greater than 10 x 10^6/l 2. Clinical safety: death, recurrent stroke, deterioration, palpable splenomegaly, at 10 days 3. Laboratory safety: white cell count (WCC, differential), platelet count (PC) | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical efficacy: 1. Impairment (SSS) 2. Disability (Barthel Index, [BI]) 3. Dependency (mRS) 4. Cognition (Mini Mental State Examination [MMSE]) 5. Depression (Zung) 6. Quality of life (EuroQOL) 7. Disposition (home, institution) Outcomes measurd at 10 and 90 days. | — |
Countries
United Kingdom
Outcome results
None listed