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| '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 |
| Source of record | UK Trials |
| ISRCTN | ISRCTN63336619 |
| Date ISRCTN assigned | 07/11/2006 |
| Local reference number(s) | Version 1.0 |
| Public title | '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 |
| Scientific title | |
| Acronym | STEMS2 |
| Disease/condition/study domain | Ischaemic stroke |
| 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. |
| Design/methodology | Randomised placebo controlled, double blind and endpoint blinded trial |
| Research ethics review | Awaited |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Clinical stroke (lacunar or cortical) 2. Ischaemic 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) |
| Participants - exclusion criteria | 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) |
| Patient information material | |
| Anticipated start date | 01/09/2006 |
| Anticipated end date | 28/02/2009 |
| Status of trial | Ongoing |
| Target number of participants | 60 |
| Interventions | 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. |
| Primary outcome measure(s) | Number of patients having a serious adverse event by day 90 |
| Secondary outcome measure(s) | 1. Laboratory measures including CD34+ count, 2. Clinical efficacy: a. impairment, b. dependency disability, c. functional independence, d. quality of life, 3. Length of stay in hospital, discharge disposition, 4. Neuroimaging: including lesion size, 5. Feasibility. |
| Sources of funding | Medical Research Council (UK) - Grant application G0501997 |
| Sponsor name | University of Nottingham (UK) |
| Sponsor details | Nottingham City Hospital Campus Hucknall Road Nottingham United Kingdom NG5 1PB |
| Sponsor website | http://www.nottingham.ac.uk/ |
| Contact name | Prof Philip Bath |
| Contact details | Stroke Trials Unit Queens Medical Centre University of Nottingham Nottingham United Kingdom NG7 2UH |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN63336619 |
| Date last extracted from ISRCTN register | 17/04/2008 |
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