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| [ ...Back to search results ] | [ Print-friendly version ] |
| Stem cell Trial of recovery EnhanceMent after Stroke 3 |
| ISRCTN | ISRCTN16714730 |
| ClinicalTrials.gov identifier | |
| Public title | Stem cell Trial of recovery EnhanceMent after Stroke 3 |
| Scientific title | Stem cell Trial of recovery EnhanceMent after Stroke 3: a randomised controlled trial |
| Acronym | STEMS3 |
| Serial number at source | 10801 |
| Study hypothesis |
Many patients are left with longstanding (chronic) disability after stroke. Despite this most patients receive no therapy beyond the first three to six months after stroke. It is unclear whether treatment with drugs or rehabilitation at this stage would improve recovery further.
Experiments in animals suggest that transplantation of stem cells (cells able to regrow and change into different cell types) can improve recovery after stroke, possibly by helping the brain to replace lost cells. Bone marrow stem cells can be released into the blood stream following injection of a drug called granulocytecolony stimulating factor (GCSF). GCSF has been tested early after stroke but has not been given to patients later after stroke. The trial design will allow us to look at the effect of GCSF and therapy in chronic stroke, and to see if the two treatments work better when given together. The results will help in the design of further trials in chronic stroke. |
| Lay summary | Lay summary under review |
| Ethics approval | Yorkshire and the Humber - Leeds East, 20 June 2011, ref: 11/YH/0138 |
| Study design | Randomised interventional treatment trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Topic: Stroke Research Network; Subtopic: Rehabilitation; Disease: Community study |
| Participants - inclusion criteria |
1. Adults (18 years and over)
2. Male and female participants 3. Motor impairment (arm or leg) with residual disability (modified Rankin Score >1) due to stroke >90 days post onset. |
| Participants - exclusion criteria |
1. Lack of residual motor deficit
2. Significant cognitive impairment that will impede ability to complete assessments 3. Diagnosis likely to interfere with outcome or rehabilitation (e.g. terminal illness) 4. Still receiving post stroke rehabilitation 5. Pregnancy 6. Other exclusions of GCSF (as per British National Formulary) |
| Anticipated start date | 01/11/2011 |
| Anticipated end date | 31/10/2013 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | Planned Sample Size: 60; UK Sample Size: 60 |
| Interventions | We will perform a trial testing both GCSF, and a course of therapy given to 60 patients who have disability at least 3 months after their stroke. The patients will be living in the community, and will be visited by the research team to be assessed for enrolment in the trial. After consent into the trial, the research nurse will give GCSF or dummy as an injection under the skin for 5 days. Following this, patients will receive therapy from trial staff for 45 minutes three times a week, for six weeks. The type and content of therapy will be dependent on the patients needs. Six weeks later the patient will be reassessed to see if there has been any change or improvement in their function. |
| Primary outcome measure(s) |
1. Feasibility
2. Proportion of participants receiving all 5 GCSF/ placebo injections 3. Proportion of participants receiving all 18 therapy sessions |
| Secondary outcome measure(s) |
1. Acceptability
2. Proportion of participants screened who are eligible for enrollment who give consent 3. Tolerability 4. Adverse events (headache, backache) reported after G-CSF administration 5. Secondary Haematological (FBC, WCC, CD34, PLT) 6. Post therapy intervention (day 45 and, end of follow-up day 90): 6.1. Motor function (RMA) 6.2. Change in dependency (modified Rankin Scale shift) 6.3. Change in disability (change in BI) 6.4. Quality of life (EuroQoL) 6.5. Care giver burden |
| Sources of funding | NIHR Research for Patient Benefit, ref:PB-PG-0909-19113 (UK) |
| Trial website | |
| Publications | |
| Contact name | Ms Nikola Sprigg |
| Address | University Park |
| City/town | Nottingham |
| Zip/Postcode | NG7 2RD |
| Country | United Kingdom |
| nikola.sprigg@nottingham.ac.uk | |
| Sponsor | University of Nottingham (UK) |
| Address |
Research Innovation Services
Kings Meadow Campus Lenton Lane |
| City/town | Nottingham |
| Zip/Postcode | NG7 2NR |
| Country | United Kingdom |
| Sponsor website: | http://www.nottingham.ac.uk/ |
| Date applied | 08/12/2011 |
| Last edited | 15/12/2011 |
| Date ISRCTN assigned | 08/12/2011 |
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