Article ; Online: A First-in-Human, Phase I Study of Neural Stem Cell Transplantation for Chronic Spinal Cord Injury.
2018 Volume 22, Issue 6, Page(s) 941–950.e6
Abstract: We tested the feasibility and safety of human-spinal-cord-derived neural stem cell (NSI-566) transplantation for the treatment of chronic spinal cord injury (SCI). In this clinical trial, four subjects with T2-T12 SCI received treatment consisting of ... ...
| Abstract | We tested the feasibility and safety of human-spinal-cord-derived neural stem cell (NSI-566) transplantation for the treatment of chronic spinal cord injury (SCI). In this clinical trial, four subjects with T2-T12 SCI received treatment consisting of removal of spinal instrumentation, laminectomy, and durotomy, followed by six midline bilateral stereotactic injections of NSI-566 cells. All subjects tolerated the procedure well and there have been no serious adverse events to date (18-27 months post-grafting). In two subjects, one to two levels of neurological improvement were detected using ISNCSCI motor and sensory scores. Our results support the safety of NSI-566 transplantation into the SCI site and early signs of potential efficacy in three of the subjects warrant further exploration of NSI-566 cells in dose escalation studies. Despite these encouraging secondary data, we emphasize that this safety trial lacks statistical power or a control group needed to evaluate functional changes resulting from cell grafting. |
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| MeSH term(s) | Adult ; Animals ; Cell Line ; Chronic Disease ; Female ; Humans ; Male ; Neural Stem Cells/cytology ; Neural Stem Cells/transplantation ; Rats ; Rats, Nude ; Spinal Cord Injuries/pathology ; Spinal Cord Injuries/surgery ; Spinal Cord Injuries/therapy ; Stem Cell Transplantation/adverse effects ; Young Adult | ||||||||||
| Language | English | ||||||||||
| Publishing date | 2018-06-01 | ||||||||||
| Publishing country | United States | ||||||||||
| Document type | Case Reports ; Clinical Trial, Phase I ; Journal Article | ||||||||||
| ZDB-ID | 2375354-7 | ||||||||||
| ISSN | 1875-9777 ; 1934-5909 | ||||||||||
| ISSN (online) | 1875-9777 | ||||||||||
| ISSN | 1934-5909 | ||||||||||
| DOI | 10.1016/j.stem.2018.05.014 | ||||||||||
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| Database | MEDical Literature Analysis and Retrieval System OnLINE |
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