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Emerging Safety of Intramedullary Transplantation of Human Neural Stem Cells in Chronic Cervical and Thoracic Spinal Cord Injury. Neurosurgery 2018 Apr 01;82(4):562-575

Date

05/26/2017

Pubmed ID

28541431

DOI

10.1093/neuros/nyx250

Scopus ID

2-s2.0-85042101089 (requires institutional sign-in at Scopus site)   129 Citations

Abstract

BACKGROUND: Human central nervous system stem cells (HuCNS-SC) are multipotent adult stem cells with successful engraftment, migration, and region-appropriate differentiation after spinal cord injury (SCI).

OBJECTIVE: To present data on the surgical safety profile and feasibility of multiple intramedullary perilesional injections of HuCNS-SC after SCI.

METHODS: Intramedullary free-hand (manual) transplantation of HuCNS-SC cells was performed in subjects with thoracic (n = 12) and cervical (n = 17) complete and sensory incomplete chronic traumatic SCI.

RESULTS: Intramedullary stem cell transplantation needle times in the thoracic cohort (20 M HuCNS-SC) were 19:30 min and total injection time was 42:15 min. The cervical cohort I (n = 6), demonstrated that escalating doses of HuCNS-SC up to 40 M range were well tolerated. In cohort II (40 M, n = 11), the intramedullary stem cell transplantation needle times and total injection time was 26:05 ± 1:08 and 58:14 ± 4:06 min, respectively. In the first year after injection, there were 4 serious adverse events in 4 of the 12 thoracic subjects and 15 serious adverse events in 9 of the 17 cervical patients. No safety concerns were considered related to the cells or the manual intramedullary injection. Cervical magnetic resonance images demonstrated mild increased T2 signal change in 8 of 17 transplanted subjects without motor decrements or emerging neuropathic pain. All T2 signal change resolved by 6 to 12 mo post-transplant.

CONCLUSION: A total cell dose of 20 M cells via 4 and up to 40 M cells via 8 perilesional intramedullary injections after thoracic and cervical SCI respectively proved safe and feasible using a manual injection technique.

Author List

Levi AD, Okonkwo DO, Park P, Jenkins AL 3rd, Kurpad SN, Parr AM, Ganju A, Aarabi B, Kim D, Casha S, Fehlings MG, Harrop JS, Anderson KD, Gage A, Hsieh J, Huhn S, Curt A, Guzman R

Author

Shekar N. Kurpad MD, PhD Sr Associate Dean, Professor in the Neurosurgery department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

Adult
Cervical Cord
Female
Humans
Male
Middle Aged
Neural Stem Cells
Spinal Cord
Spinal Cord Injuries
Stem Cell Transplantation
Young Adult