Chen 2014.
Methods | Single‐blind, randomized, controlled clinical trial | |
Participants | 30 participants with chronic MCA infarction and neurological deficits of intermediate severity Treatment 15, control 15 Treated between 6 months and 5 years from stroke onset |
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Interventions | Subcutaneous granulocyte‐colony stimulating factor injections (15 μg/kg/day) for 5 consecutive days, followed by stereotaxic implantation of autologous 3 to 8 million CD34+ immunosorted peripheral blood stem cells | |
Outcomes | Improvements in stroke scales (NIHSS, European Stroke Scale, and European Stroke Scale Motor Subscale) and functional outcomes measure (mRS) from baseline to the end of the 12‐month follow‐up | |
Notes | None | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were assigned randomly (1:1) via SAS software to either the peripheral blood stem cells or the control groups |
Allocation concealment (selection bias) | Low risk | Participants were correctly allocated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Experimental procedures (such as stereotaxic implantation) were not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | All clinical information was assessed by clinician raters in a single‐blinded fashion (at clinical evaluation, each participant wore a hat to mask the surgical scar on their skull) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data were complete |
Selective reporting (reporting bias) | Low risk | Primary outcomes listed in published protocols were adequately reported in the results |
Other bias | Low risk | Granulocyte‐colony stimulating factor may be neuroprotective in the acute phase, but this trial included participants treated between 6 months and 5 years from stroke onset |