Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
Version 1.3 28/06/04
Study information
Scientific title
Acronym
STEMS
Study hypothesis
Loss of motor function is common after stroke and often leads to significant long-term disability. Stem cells can be mobilised into the circulation using granulocyte-colony stimulating factor (G-CSF), an approach that has been found to be effective in experimental stroke. We aim to perform a pilot randomised placebo-controlled dose-escalation trial of 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 µkg - 3 x 10^6 µ/kg, with level of 5 dose blocks depending on single dose data) in patients with motor weakness following ischaemic stroke, investigating its safety, feasibility of administration, tolerability, and effects on stem cell mobilisation, impairment, disability and dependency. The interaction between G-CSF and routine rehabilitation will be examined.
The study will last 24 months with 42 patients recruited over 19 months allowing 3 months follow-up. The results will help inform the design (inclusion criteria, outcomes, size) of further trials including the planning of a large definitive trial assessing the safety and efficacy (motor recovery and functional outcome) of G-CSF.
Ethics approval
Ethics approval received from the Nottingham Local Research Committee on the 5th June 2003 and had Medicines and Healthcare Products Regulatory Agency Clinical Trial Authorisation on the 10th March 2003).
Study design
Randomised placebo controlled pilot trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Stroke (ischaemic)
Intervention
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 x 10^6 µ/kg, with level of 5 dose blocks depending on single dose data.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 outcome measures
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.
Overall trial start date
01/08/2003
Overall trial end date
01/08/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
42
Participant 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
Recruitment start date
01/08/2003
Recruitment end date
01/08/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Nottingham
Nottingham
NG5 1PB
United Kingdom
Sponsor information
Organisation
University of Nottingham (UK)
Sponsor details
Clinical Sciences Building
Nottingham City Hospital Campus
Nottingham
NG5 1PB
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
The Stroke Association (UK) (ref: TSA 01/03)
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17082474
Publication citations
-
Results
Sprigg N, Bath PM, Zhao L, Willmot MR, Gray LJ, Walker MF, Dennis MS, Russell N, Granulocyte-colony-stimulating factor mobilizes bone marrow stem cells in patients with subacute ischemic stroke: the Stem cell Trial of recovery EnhanceMent after Stroke (STEMS) pilot randomized, controlled trial (ISRCTN 16784092)., Stroke, 2006, 37, 12, 2979-2983, doi: 10.1161/01.STR.0000248763.49831.c3.