Condition category
Circulatory System
Date applied
22/05/2006
Date assigned
07/11/2006
Last edited
16/08/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Philip Bath

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Version 1.0

Study information

Scientific title

Acronym

STEMS2

Study hypothesis

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

Ethics approval received from the Nottingham LREC 1 on the 22nd May 2007 (ref: 07/Q2403/27).

Study design

Randomised placebo controlled double blind and endpoint blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Filgrastrim

Primary outcome measures

Number of patients having a serious adverse event by day 90.

Secondary outcome measures

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

Overall trial start date

02/07/2007

Overall trial end date

31/03/2010

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

60

Participant 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)

Recruitment start date

02/07/2007

Recruitment end date

31/03/2010

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Stroke Trials Unit
Nottingham
NG7 2UH
United Kingdom

Sponsor information

Organisation

University of Nottingham (UK)

Sponsor details

Nottingham City Hospital Campus
Hucknall Road
Nottingham
NG5 1PB
United Kingdom

Sponsor type

University/education

Website

http://www.nottingham.ac.uk/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) - Grant application G0501997

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22198983

Publication citations

  1. Results

    England TJ, Abaei M, Auer DP, Lowe J, Jones DR, Sare G, Walker M, Bath PM, Granulocyte-colony stimulating factor for mobilizing bone marrow stem cells in subacute stroke: the stem cell trial of recovery enhancement after stroke 2 randomized controlled trial., Stroke, 2012, 43, 2, 405-411, doi: 10.1161/STROKEAHA.111.636449.

Additional files

Editorial Notes