Stem cell Trial of recovery EnhanceMent after Stroke 2 (STEMS 2) pilot randomised controlled trial

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Disordered movement is a common result of stroke and causes considerable physical disability and distress. Stem cells are a potential source of new brain and supporting cells, either by directly changing into the different cell types, or by stimulating local brain stem cells to change. Bone marrow stem cells (so-called CD34+ cells) may be moved into the blood circulation using granulocyte-colony stimulating factor (G-CSF), a naturally occurring hormone which controls certain bone marrow cells. We have previously completed a pilot randomised trial of G-CSF in 36 patients with recent stroke; G-CSF increased blood CD34+ cell counts by up to ten times depending on dose. G-CSF appeared safe and we now need to explore how the increase in circulating CD34+ cells might improve outcome after stroke. We have started a second pilot trial in 60 patients recruited 7 days after stroke onset to further assess the effects of G-CSF on safety. We are using magnetic resonance imaging of the brain to assess whether the site of damage reduces in size, whether cell content recovers in this area, whether connections between cells re-develop, whether the blood supply in this area improves, and whether CD34+ cells can be tracked moving to the damaged stroke region. If patients die, examination of the brain under a microscope will be performed assessing whether CD34+ stem cells are present in area of the stroke. If this study supports the idea that G-CSF may aid recovery after stroke, the results will help in the design of future trials of G-CSF in recent stroke. Even if the trial shows no effect, lessons from the study will provide useful information on how future trials of stem cells might be performed. If subsequent trials are positive, routine use of G-CSF would benefit patients and society, reduce load on carers and health care, and contribute to the UK Government‘s health strategy.