Condition category
Circulatory System
Date applied
26/08/2005
Date assigned
31/10/2005
Last edited
20/12/2007
Prospective/Retrospective
Retrospectively 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

University of Nottingham
Clinical Sciences Building
Nottingham City Hospital Campus
Nottingham
NG5 1PB
United Kingdom

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 measures

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

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

http://www.nottingham.ac.uk

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

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17082474

Publication citations

  1. 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.

Additional files

Editorial Notes