'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
- Conditions
- Ischaemic strokeCirculatory SystemStroke
- Registration Number
- ISRCTN63336619
- Lead Sponsor
- niversity of Nottingham (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
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)
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)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of patients having a serious adverse event by day 90.
- Secondary Outcome Measures
Name Time Method 1. Laboratory measures including CD34+ count<br>2. Clinical efficacy: <br>2.1. Impairment<br>2.2. Dependency disability<br>2.3. Functional independence<br>2.4. Quality of life<br>3. Length of stay in hospital, discharge disposition<br>4. Neuroimaging: including lesion size<br>5. Feasibility