Table 3.
Spinal Cord Injury Clinical Trials using NSC-based therapies.
| Start Year | Sponsor | Country | NTC/I.D. | Clinical Phase | SCI Cohort | Cell-Type | Cell Source | Safety | Improvements | Others | REF |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2005 | Yonsei University Health System, Severance Hospital | KR | KCT0000879 | Phase I/II | Cervical | hNSPCs | Fetal brain | Safe and well-tolerable | Partial sensorimotor function | No cord damage, syrinx or tumor formation No neurological deterioration, and exacerbating neuropathic pain or spasticity Incomplete sensory recovery |
[176] |
| 2011 | StemCells, Inc. | CAN CH |
NCT01321333 | Phase I/II | T2-T11 | HuCNS-SCs | Fetal brain | Safe and well-tolerable | Segmental sensory | Decline in sensory gains lost after withdrawal of the immunosuppressive | [168] |
| 2012 | StemCells, Inc. | CH | NCT01725880 | Phase I/II | T2-T11 | HuCNS-SCs | Fetal brain | Study terminated based on a business decision | [177] | ||
| 2013 | Neuralstem Inc. | US | NCT01772810 | Phase I | T2-T12 | NSI-566 cell line | Fetal spinal cord (cervical and upper thoracic regions) | Safe and no side effects 18–27 months after cell delivery | Low sample size (n = 4) Still Recruiting |
[178] | |
| 2014 | StemCells, Inc. | US CAN |
NCT02163876 | Phase I/II | C5-C7 | HuCNS-SCs | Fetal brain | Slight motor strength but the study was terminated based on a business decision | [179] | ||
| 2017 | University of Zurich | CH | NCT03069404 | Phase I/II | T2-T11 | HuCNS-SCs | Fetal brain | No data | [180] | ||
| 2014 | Federal Research Clinical Center of Federal Medical & Biological Agency | RU | NCT02326662 | Phase I/II | Neck, thoracic or lumbar | drNSCs | BMCs | Safe with any complications | Neurologic state | [181] | |
| 2016 | Chinese Academy of Sciences | CN | NCT02688049 | Phase I/II | C5-T12 | NSCs | No data Still recruiting |
[182] | |||
| 2010 | Asterias Biotherapeutics | US | NCT01217008 | Phase I | Neurologically Complete, Subacute | GRNOPC1 | hESCs | The study was terminated based on financial issues | [183] | ||
| 2015 | Asterias Biotherapeutics | US | NCT02302157 | Phase I/II | C4-C7 | AST-OPC1 | hESCs | Favorable safety profile | Some hand functions | [184] |
Abbreviations: T thoracic; US United States; CAN Canada; CH Switzerland; CN China; RU Russian Federation; KR Republic of Korea; NSCs neural stem cells; hESCs human embryonic stem cells; BMCs bone marrow cells; HuCNS-SCs human central nervous system stem cells; NSI-566 cell line human spinal-cord-derived NSC; drNSC directly reprogrammed autologous NSCs; AST-OPC1 AST-oligodendrocyte progenitor cells; GRNOPC1 human embryonic stem cell-derived OPCs.