Stem cell Trial of recovery EnhanceMent after Stroke 3 (STEMS 3)

• Research type

  Research Study

• Full title

  'Stem cell Trial of recovery EnhanceMent after Stroke 3’ (STEMS 3)- a pilot randomised controlled trial of G-CSF and therapy in chronic stroke

• IRAS ID

  75187

• Eudract number

  2011-001684-50

• ISRCTN Number

  awaited

• Clinicaltrials.gov Identifier

  awaited

• Research summary

  Many patients are left with longstanding (chronic) disability after stroke. Despite this most patients receive no therapy beyond the first three-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 re-grow 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 granulocyte-colony stimulating factor (G-CSF). G-CSF has been tested early after stroke but has not been given to patients later after stroke. We will perform a trial testing both G-CSF, and a course of rehabilitation 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 G-CSF or dummy as an injection under the skin for 5 days. Following this, half the patients will receive rehabilitation therapy from trial staff for 45 minutes three times a week, for six weeks. The type and content of rehabilitation therapy will be dependent on the patients needs. The other half of patients will not receive any rehabilitation therapy. Six weeks later all the patients will be re-assessed to see if there has been any change or improvement in their function.The trial design will allow us to look at the effect of G-CSF and rehabilitation 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.

• REC name

  Yorkshire & The Humber - Leeds East Research Ethics Committee

• REC reference

  11/YH/0138

• Date of REC Opinion

  20 Jun 2011

• REC opinion

  Further Information Favourable Opinion