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Table 1 Disposition of study design & intervention characteristics

From: Safety and effectiveness of stem cell therapies in early-phase clinical trials in stroke: a systematic review and meta-analysis

Study variable Number of studies Number of subjects
Studies included 26 844
Country
 United States 5 45
 United Kingdom 2 16
 Brazil 3 43
 China 4 366
 India 4 195
 South Korea 2 82
 Japan 2 24
 Spain 1 10
 Taiwan 1 30
 Cuba 1 5
 Russia 1 10
Stroke phase
 Hyper-acute/acute/sub-acute 15 597
 Chronic 12 247
 Stroke type
 Ischaemic 20 421
 Ischaemic + haemorrhagic 5 77
 Haemorrhagic 2 346
Stem cell characteristics
 Cell type
  Human bone marrow-derived MSC/MNC 18 698
  Human fetal neural stem/progenitor cells 3a 67
  Umbilical mesenchymal stem cells 1 14
  Porcine fetal cells 1 5
  Human embryonic neuronal cells 2 19
  Peripheral blood haematopoietic stem cells 1 30
 Cell source
  Allogeneic 8 134
  Autologous 18 710
 Route of administration
  Intra-arterial 6b 57
  Intracerebral 9c 405
  Intravenous 11b 332
  Intrathecal 2c 256
 Time between stroke onset and stem cell transplantation
  < 3 months 13d 567
  > 3 months 14d 283
Study design
 RCT 6 390
 Non-RCT (case–control design) 4 280
 Non-RCT (historic control) 1 10
 Single-arm open-label design 15 97
Provision of rehabilitation
 RCT
  Yes 4  
  No 1  
  Not reported 1  
 Non-RCT
  Yes 1  
  No 4  
  Not reported 14  
  1. MSC mesenchymal stem cells, MNC mononuclear cells, RCT randomised controlled trial
  2. aCo-transplantation of neural stem cells and umbilical cord MSC
  3. bOne study had two unmatched sequential cohorts investigated under different routes of administration
  4. bA treatment cycle in one study used transplants via intracerebral route followed by 4 weeks of intravenous infusion
  5. dOne study reported administration of stem cell therapy in two settings (1st setting before and 2nd after 3 months of stroke)