'Stem cell Trial of recovery EnhanceMent after Stroke 2' (STEMS2): pilot randomised placebo-controlled trial of granulocyte-colony stimulating factor in mobilising bone marrow stem cells in sub-acute stroke

ISRCTN	ISRCTN63336619
DOI	https://doi.org/10.1186/ISRCTN63336619
Protocol serial number	Version 1.0
Sponsor	University of Nottingham (UK)
Funder	Medical Research Council (MRC) (UK) - Grant application G0501997

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Philip Bath
Scientific

Stroke Trials Unit
Queens Medical Centre
University of Nottingham
Nottingham
NG7 2UH
United Kingdom

Primary study design	Interventional
Study design	Randomised placebo controlled double blind and endpoint blinded trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	STEMS2
Study objectives	We hypothesise that Granulocyte Colony Stimulating Factor (G-CSF) mobilised Peripheral Blood Stem Cells (PBSCs) in patients with recent ischaemic stroke will migrate to the brain and promote recovery.
Ethics approval(s)	Ethics approval received from the Nottingham LREC 1 on the 22nd May 2007 (ref: 07/Q2403/27).
Health condition(s) or problem(s) studied	Ischaemic stroke
Intervention	Subcutaneous human recombinant G-CSF (Filgrastrim 1 x 106 u/kg) versus saline started three to 30 days after stroke onset and given for five days.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Filgrastrim
Primary outcome measure(s)	Number of patients having a serious adverse event by day 90.
Key secondary outcome measure(s)	1. Laboratory measures including CD34+ count 2. Clinical efficacy: 2.1. Impairment 2.2. Dependency disability 2.3. Functional independence 2.4. Quality of life 3. Length of stay in hospital, discharge disposition 4. Neuroimaging: including lesion size 5. Feasibility
Completion date	31/03/2010

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	60
Key inclusion criteria	1. Clinical stroke (lacunar or cortical) 2. Ischaemic or haemorrhagic type on neuro-imaging three to 30 days post-onset 3. Arm and/or leg weakness (Scandinavian Stroke Scale [SSS] arm and/or leg motor power less than six)
Key exclusion criteria	Prior to 09/09/09: 1. Pre-morbid dependency, modified Rankin Scale (mRS) more than three 2. Primary intracerebral haemorrhage 3. Dementia 4. Coma (SSS consciousness less than four) 5. Malignancy 6. Sickle cell disease 7. Pregnancy (see data sheet/British National Formulary [BNF] for other G-CSF contra-indications) 8. Known contra-indication to Magnetic Resonance Imaging (MRI) Amended 09/09/09: 1. Pre-morbid dependency, modified Rankin Scale (mRS) more than three 2. Dementia 3. Coma (SSS consciousness less than four) 4. Malignancy 5. Sickle cell disease 6. Pregnancy (see data sheet/British National Formulary [BNF] for other G-CSF contra-indications) 7. Known contra-indication to Magnetic Resonance Imaging (MRI)
Date of first enrolment	02/07/2007
Date of final enrolment	31/03/2010

Stroke Trials Unit

Nottingham
NG7 2UH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2012		Yes	No