Journal article
Emerging Safety of Intramedullary Transplantation of Human Neural Stem Cells in Chronic Cervical and Thoracic Spinal Cord Injury.
- Levi AD Department of Neurological Surgery and the Miami Project to Cure Paralysis, University of Miami Miller School of Medicine, Miami, Florida.
- Okonkwo DO Department of Neurosurgery, University of Pittsburgh, Pittsburgh, Pennsylvania.
- Park P Department of Neurosurgery, University of Michigan, Ann Arbor, Michigan.
- Jenkins AL Department of Neurosurgery, Icahn School of Medicine at Mount Sinai, New York, New York.
- Kurpad SN Department of Neurosurgery, Medical College of Wisconsin, Milwaukee, Wisconsin.
- Parr AM Department of Neurosurgery, University of Minnesota, Minneapolis, Minnesota.
- Ganju A Department of Neurological Surgery, Northwestern Feinberg School of Medicine, Chicago, Illinois.
- Aarabi B Department of Neurosurgery, University of Maryland, College Park, Maryland.
- Kim D Department of Neurosurgery, University of Texas Health Science Center, Austin, Texas.
- Casha S Department of Clinical Neurosciences and the Hotchkiss Brain Institute, University of Calgary, Calgary, Alberta, Canada.
- Fehlings MG Division of Neurosurgery and Spinal Program, University Health Network, University of Toronto, Toronto, Ontario, Canada.
- Harrop JS Department of Neurological Surgery, Thomas Jefferson University Hospital, Philadelphia, Pennsylvania.
- Anderson KD Department of Neurological Surgery and the Miami Project to Cure Paralysis, University of Miami Miller School of Medicine, Miami, Florida.
- Gage A Stem Cells Inc., Newark, California.
- Hsieh J Stem Cells Inc., Newark, California.
- Huhn S Stem Cells Inc., Newark, California.
- Curt A Spinal Cord Injury Unit, Balgrist University Hospital, Zürich, Switzerland.
- Guzman R Department of Neurosurgery, University Hospital Basel, Basel, Switzerland.
- 2017-05-26
Published in:
- Neurosurgery. - 2018
Adult
Cervical Cord
Female
Humans
Male
Middle Aged
Neural Stem Cells
Spinal Cord
Spinal Cord Injuries
Stem Cell Transplantation
Young Adult
English
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.
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.
- Language
-
- English
- Open access status
- closed
- Identifiers
-
- DOI 10.1093/neuros/nyx250
- PMID 28541431
- Persistent URL
- https://sonar.ch/global/documents/103162
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