Intracerebral implantation of autologous peripheral blood stem cells in stroke patients: a randomized phase II study.
In our previous study, intracerebral implantation of peripheral blood stem cells (PBSCs) improved functional outcome in rats with chronic cerebral infarction. Based on this finding, 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 a 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 µg/kg/day) for 5 consecutive days, and then stereotaxic implantation of 3-8 × 10(6) CD34(+) immunosorted PBSCs. All 30 patients completed the 12-month follow-up. No serious adverse events were noted during study period. Improvements in stroke scales (NIHSS, ESS, and EMS) and functional outcomes (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 (DTI) tractography were reduced in every PBSC-treated subject, but not in the control group. Reduction in the FNA scores correlated well with the improvement in NIHSS. Furthermore, a positive motor-evoked potential (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.
Center for Neuropsychiatry, China Medical University Hospital, Taichung, Taiwan.
Der-Cherng
DC
Chen
Shinn-Zong
SZ
Lin
Jia-Rong
JR
Fan
Chen-Huan
CH
Lin
Wei
W
Lee
Chao-Chun
CC
Lin
Yi-Jui
YJ
Liu
Chon-Haw
CH
Tsai
Jui-Cheng
JC
Chen
Der-Yan
DY
Cho
Chau-Chin
CC
Lee
Woei-Cherng
WC
Shyu
D000328:Adult; D000368:Aged; D003710:Demography; D056324:Diffusion Tensor Imaging; D019054:Evoked Potentials, Motor; D005260:Female; D005500:Follow-Up Studies; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects; D006412:Hematopoietic Stem Cells / Q000166:cytology*; D006801:Humans; D008297:Male; D008875:Middle Aged; D020521:Stroke / Q000503:physiopathology / Q000628:therapy*; D013997:Time Factors; D014182:Transplantation, Autologous; D016896:Treatment Outcome