A randomised placebo-controlled pilot trial of granulocyte-colony stimulating factor in mobilising bone marrow stem cells in sub-acute stroke: the 'Stem cell Trial of recovery EnhanceMent after Stroke' (STEMS) pilot study
| ISRCTN | ISRCTN16784092 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16784092 |
| Secondary identifying numbers | Version 1.3 28/06/04 |
- Submission date
- 26/08/2005
- Registration date
- 31/10/2005
- Last edited
- 20/12/2007
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Philip Bath
Scientific
Scientific
University of Nottingham
Clinical Sciences Building
Nottingham City Hospital Campus
Nottingham
NG5 1PB
United Kingdom
Study information
| Study design | Randomised placebo controlled pilot trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | STEMS |
| Study objectives | 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(s) | 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). |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/08/2003 |
| Completion date | 01/08/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 42 |
| Key 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) |
| Key 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 |
| Date of first enrolment | 01/08/2003 |
| Date of final enrolment | 01/08/2006 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Nottingham
Nottingham
NG5 1PB
United Kingdom
NG5 1PB
United Kingdom
Sponsor information
University of Nottingham (UK)
University/education
University/education
Clinical Sciences Building
Nottingham City Hospital Campus
Nottingham
NG5 1PB
England
United Kingdom
| Website | http://www.nottingham.ac.uk |
|---|---|
"ROR" |
https://ror.org/01ee9ar58 |
Funders
Funder type
Charity
The Stroke Association (UK) (ref: TSA 01/03)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/12/2006 | Yes | No |
