Authors:
Chen DC, Lin SZ, Fan JR, Lin CH, Lee W, Lin CC, Liu YJ, Tsai CH, Chen JC, Cho DY, Lee CC, & Shyu WC
Summary:
In our previous study, intracerebral implantation of peripheral blood stem cells (PBSC) improved functional outcome in rats with chronic cerebral infarction. Based on this findings, a randomized, single blind controlled study was conducted in 30 patients [PBSC group (n=15) and control group (n=15)] with middle cerebral artery infarction confirmed on T2?weighted MRI 6 months to 5 years after a stroke. Only subjects with neurological deficits of intermediate severity based on the National Institute of Health Stroke Scale (NIHSS) (range: 9?20) that had been stable for at least 3 months were enrolled. Those in the PBSC group received subcutaneous G?CSF injections (15 ?g/kg/d) for 5 consecutive days and then stereotaxic implantation of 3?8 x 106CD34+immunosorted PBSCs. All 30 patients completed the 12?month follow?up. No serious adverse events were noted during study peroid. Improvements in stroke scales (NIHSS, ESS and EMS) and functional outcome (mRS) from baseline to the end of the 12?month follow?up period were significantly greater in the PBSC than the control group. The fiber numbers asymmetry (FNA) scores based on diffusion tensor image tractography (DTI) were reduced in every PBSC?treated subject, but not in the control group. Reduction in FNA score was correlated well with improvement in NIHSS. Furthermore, a positive motor evoked potentials (MEP) response by transcranial magnetic stimulation (TMS) appeared in 9 of the 15 subjects in the PBSC group. This phase II study demonstrated that implantation of autologous CD34+PBSC was safe, feasible, and effective in improving functional outcome.
Source:
Cell Transplantation; (01/29/14)