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02 September 2010
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| [ Print-friendly version ] |
| '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 |
| ClinicalTrials.gov identifier | |
| 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 |
| Serial number at source | Version 1.0 |
| 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 |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Ischaemic stroke |
| Participants - 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) |
| Participants - 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) |
| Anticipated start date | 02/07/2007 |
| Anticipated end date | 31/03/2010 |
| Status of trial | Completed |
| Patient information material | |
| 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: 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 |
| Sources of funding | Medical Research Council (MRC) (UK) - Grant application G0501997 |
| Trial website | |
| Publications | |
| Contact name | Prof Philip Bath |
| Address |
Stroke Trials Unit
Queens Medical Centre University of Nottingham |
| City/town | Nottingham |
| Zip/Postcode | NG7 2UH |
| Country | United Kingdom |
| Sponsor | University of Nottingham (UK) |
| Address |
Nottingham City Hospital Campus
Hucknall Road |
| City/town | Nottingham |
| Zip/Postcode | NG5 1PB |
| Country | United Kingdom |
| Sponsor website: | http://www.nottingham.ac.uk/ |
| Date applied | 22/05/2006 |
| Last edited | 09/09/2009 |
| Date ISRCTN assigned | 07/11/2006 |
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| © 2010 ISRCTN unless otherwise stated. | |
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