'Stem cell Trial of recovery EnhanceMent after Stroke 3’ (STEMS 3)- a pilot randomised controlled trial of G-CSF and therapy in chronic stroke

INTERVENTION: Trade Name: Filgrastim (Neupogen) Product Name: FILGRASTIM Product Code: 16216/0038 Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Stroke with residual deficit PRIMARY OUTCOME: Main Objective: To assess the safety, feasibility, and tolerability of delivering the drug G‐CSF and or rehabilitation therapy in chronic stroke patients. Primary end point(s): Feasibility: proportion of participants receiving all 5 G‐CSF/placebo injections; proportion of participants receiving all therapy sessions. Acceptability‐ proportion of participants screened who are eligible for enrollment who give consent; Tolerability‐ Adverse events (headache, backache) reported after G‐CSF adminisitration; proportion of participants who withdraw or decline rehabiliation therapy sessions. Secondary Objective: 1) To study potential interaction between the drug G‐CSF and rehabilitation therapy in chronic stroke patients. 2) Finalise the design including the sample size calculations and outcome measures for the definitive trial, by obtaining information on functional measures, the spectrum of disability among trial recruits and the completeness of outcome data. INCLUSION CRITERIA: Adults (18 years and over) with motor impairment (arm or leg) with residual disability (modified Rankin Score >1) due to stroke >90 days post onset. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range