Table 2.
Completed Clinical Trials of MSCs in the Treatment of SCI
| Clinical Trials. Gov Identifier | Status | Phase(s) (No. Enrolled) | Completion Date | Primary End Point | Ages (Years) | Intervention | Transplantation | Findings |
|---|---|---|---|---|---|---|---|---|
| NCT02482194 | Completed | I (N=9) | Mar 2016 | Safety | 18~50 | Autologous BM-MSCs | Intrathecal | Intrathecal injection of BMMSCs is safe with no serious adverse event |
| NCT01676441 | Terminated | II/III (N=20) | Mar 2021 | Safety, ASIA score | 16~65 | Autologous BM-MSCs | Intrathecal | Patients receiving BM-MSCs demonstrate improved in the muscle tension and in ADL, as well as significant MRI and electrophysiological changes |
| NCT02481440 | Completed | I/II (N=102) | Mar 2020 | Safety, ASIA score | 18~65 | Allogeneic hUC-MSCs | Intrathecal | Intrathecal injection of hUC-MSCs is safe with no serious adverse event |
| NCT02152657 | Completed | N/A (N=5) | Dec 2016 | Safety, MRI | 18~65 | Autologous MSCs | Percutaneous | N/A |
| NCT02981576 | Completed | I/II (N=14) | Jan 2019 | Safety and efficacy, ASIA score, MRI | 18~70 | Autologous BM-MSCs and AD-MSCs | Intrathecal | N/A |
| NCT02570932 | Completed | II (N=10) | Dec 2017 | IANR-SCIFRS | 18~70 | Autologous BM-MSCs | Intrathecal | Patients receiving BM-MSCs show variable clinical improvement in sensitivity, motor power, spasms, spasticity, neuropathic pain, sexual function or sphincter dysfunction without any adverse event |
| NCT01769872 | Completed | I/II (N=15) | Jan 2016 | Safety and effect, ASIA score | 19~70 | Autologous AD-MSCs | Intrathecal | N/A |
| NCT01274975 | Completed | I (N=8) | Feb 2010 | Safety | 19~60 | Autologous AD-MSCs | Intravenous | N/A |
| NCT01624779 | Completed | I (N=15) | May 2014 | MRI | 19~70 | Autologous AD-MSCs | Intrathecal | N/A |
| NCT04288934 | Completed | I (N=20) | Sep 2020 | ASIA score, ISNCSCI, SCIM III | 18~70 | Autologous BM-MSCs, WJ-MSCs | Intralesional. | N/A |
| NCT01873547 | Completed | III (N=300) | Dec 2015 | Safety, ASIA score | 20~65 | Allogeneic UC-MSCs | Intrathecal | N/A |
| NCT01909154 | Completed | I (N=12) | Mar 2015 | Safety | 18~60 | Autologous BM-MSCs | Intrathecal | Intrathecal administration of BM-MSCs is safe with no adverse events |
| NCT00816803 | Completed | I/II (N=80) | Dec 2008 | Safety, MRI | 10~36 | Autologous BM-MSCs | Intrathecal | Intrathecal injection of BM-MSC is safe with no long-term cell therapy-related side effects |
| NCT02165904 | Completed | I (N=10) | May 2016 | ASIA score | 18~70 | Autologous BM-MSCs | Intrathecal | Patients treated with BM-MSCs show improvements in sensitivity, motor function, sexual function and urinary control |
| NCT02510365 | Unknown | I (N=20) | Dec 2021 | Safety and efficacy | 18~65 | Allogeneic UC-MSCs | Intralesional | UC-MSCs transplantation is safe with no obvious adverse symptoms |
| NCT01393977 | Unknown | II (N=60) | May 2012 | EET | 20~50 | Allogeneic UC-MSCs | Intrathecal | Patients receiving UC-MSCs demonstrate improved self-care ability, muscular tension, maximum urinary flow rate as well as maximum bladder capacity |
| NCT01162915 | Suspended | I (N=10) | May 2014 | Safety | 18~65 | Autologous BM-MSCs. | Intrathecal | N/A |
| NCT01325103 | Completed | N/A (N=14) | Dec 2012 | Safety | 18~50 | Autologous BM-MSCs | Intralesional | Patients treated with BM-MSCs show improvement in both urinary and nervous system function and AISA score |
| NCT03003364 | Completed | I/II (N=10) | Feb 2020 | Safety | 18~ 65 | Allogeneic WJ-MSCs | Intrathecal | Intrathecal transplantation of WJ-MSCs is safe with no significant side effects |
| NCT01694927 | Unknown | II (N=30) | Jun 2014 | Safety | 2~65 | Autologous MSCs | Intrathecal | N/A |
| NCT02574572 | Unknown | I (N=10) | Jun 2020 | MRI | 18~65 | Autologous MSCs | Intralesional | N/A |
| NCT01446640 | Unknown | I/II (N=20) | Jun 2014 | Safety | 16~60 | Autologous BM-MSCs | Intrathecal | N/A |
| NCT02688049 | Unknown | I/II (N=30) | Dec 2021 | ASIA score, SSEP, MEP | 18~65 | Autologous BM-MSCs | Intralesional | N/A |
| NCT02352077 | Unknown | I (N=30) | Dec 2021 | Safety | 18~65 | Autologous BM-MSCs | Intralesional | N/A |
| NCT05018793 | Suspended | I (N=15) | Dec 2025 | Safety | Child, adult, older | Autologous AD-MSCs | Intrathecal | Intrathecal administration of AD-MSCs is safe with no adverse events |
| NCT04213131 | Unknown | N/A (N=42) | Jan 2021 | Neurologic function score, ASIA score | 20~65 | Allogeneic hUC-MSCs | Intravenous | N/A |
Abbreviations: ASIA, American spinal injury association; ISNCSCI, international standards for neurological classification of SCI; MEP, motor evoked potentials; SSEP, somatosensory evoked potentials; MRI, magnetic resonance imaging; SCIM, spinal cord independence measure; IANR-SCIFRS, neurorestoratology-spinal cord injury functional rating scale; N/A, not applicable; EET, electromyogram and electroneurophysiologic test; hUC-MSCs, human umbilical cord-derived mesenchymal stem cells; UC-MSCs, umbilical cord derived mesenchymal stem cells; AD-MSCs, adipose tissue-derived mesenchymal stem cells; WJ-MSCs, wharton’s jelly mesenchymal stem cells.